NDC 0942-6478 Cpd/adsol Red Cell Preservation Solution System (pl 2209)

Anticoagulant Citrate Phosphate Dextrose (cpd) Solution And Adsol Preservation Solution

NDC Product Code 0942-6478

NDC Code: 0942-6478

Proprietary Name: Cpd/adsol Red Cell Preservation Solution System (pl 2209) What is the Proprietary Name?
The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.

Non-Proprietary Name: Anticoagulant Citrate Phosphate Dextrose (cpd) Solution And Adsol Preservation Solution What is the Non-Proprietary Name?
The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.

NDC Code Structure

  • 0942 - Fenwal, Inc.
    • 0942-6478 - Cpd/adsol Red Cell Preservation Solution System (pl 2209)

NDC 0942-6478-03

Package Description: 1 KIT in 1 KIT * 70 mL in 1 BAG * 110 mL in 1 BAG

NDC Product Information

Cpd/adsol Red Cell Preservation Solution System (pl 2209) with NDC 0942-6478 is a a human prescription drug product labeled by Fenwal, Inc.. The generic name of Cpd/adsol Red Cell Preservation Solution System (pl 2209) is anticoagulant citrate phosphate dextrose (cpd) solution and adsol preservation solution. The product's dosage form is kit and is administered via form.

Labeler Name: Fenwal, Inc.

Dosage Form: Kit - A packaged collection of related material.

Product Type: Human Prescription Drug What kind of product is this?
Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.

Inactive Ingredient(s)

About the Inactive Ingredient(s)
The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product.

  • SODIUM HYDROXIDE (UNII: 55X04QC32I)

Product Labeler Information

What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.

Labeler Name: Fenwal, Inc.
Labeler Code: 0942
FDA Application Number: BN900223 What is the FDA Application Number?
This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.

Marketing Category: NDA - A product marketed under an approved New Drug Application. What is the Marketing Category?
Product types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.

Start Marketing Date: 01-31-2008 What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.

Listing Expiration Date: 12-31-2019 What is the Listing Expiration Date?
This is the date when the listing record will expire if not updated or certified by the product labeler.

Exclude Flag: N What is the NDC Exclude Flag?
This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA’s requests for correction to deficient or non-compliant submissions. Values = ‘Y’ or ‘N’.

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Cpd/adsol Red Cell Preservation Solution System (pl 2209) Product Labeling Information

The product labeling information includes all published material associated to a drug. Product labeling documents include information like generic names, active ingredients, ingredient strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Product Labeling Index

Blood-Pack Unit With An Integral Sepacell Flex-Excel Leukocyte Reduction Filter Using Cpd/Adsol Red Cell Preservation Solution For Whole Blood Collection And Filtration Of Red Blood Cells

  • Rx onlyContains Y-Sampling Site for the collection of unanticoagulated whole blood samples for laboratory testing and the DonorCare Needle Guard.Integral filter unit intended for leukocyte reduction of AS-1 Red Blood Cells: •At ambient temperature up to 8 hours after blood collection. •At refrigerated temperature up to 3 days after blood collection if AS-1 Red Blood Cells are prepared within 3 days after whole blood collection.The leukocyte reduced Red Blood Cells may then be stored for the maximum allowable dating period.This Product Contains Dry Natural Rubber.Instructions for UseCollection Procedure: Use aseptic technique.Note: Nominal tubing dimensions of product are 0.118" inner diameter x 0.025" wall thickness.Note: If the Y-Sampling Site is not used, donor samples may be collected using an alternate method following standard procedures.Precautions: •Do not use unless the solutions are clear. •Before beginning procedure, obtain one access device for each Blood-Pack Unit with Y-Sampling Site to be processed. 1.Identify Blood-Pack Unit using appropriate donor identification system. 2.Adjust donor scale to desired collection weight and position primary container on the donor scale as far as possible below donor arm. 3.Clamp donor tubing between needle and Y-Sampling Site with hemostat. This step may be performed prior to step 1 or 2. 4.Apply pressure to donor’s arm and disinfect site of venipuncture. 5.If blood pressure cuff is used, inflate to approximately 60 mmHg. 6.Remove needle cover per instructions below:a)Holding the hub and cover near the tamper-evident seal, twist cover 1/4 turn to break seal.b)Remove needle cover, being careful not to drag the cover across the needle point. 7.Perform venipuncture, appropriately secure donor needle and/or tubing and release hemostat. 8.When good blood flow is established, slide the DonorCare needle guard over the needle hub into the engaged position. Leave the front third of the needle hub exposed for access. Stabilize the front of the needle guard to arm with tape (see Figure 1).Note: In difficult collection conditions (e.g., slow blood flow), leave the needle guard disengaged behind the hub during collection. Engage the needle guard at the end of blood collection. 9.Mix blood and anticoagulant in primary container at several intervals during collection and immediately after collection. 10.Collect the appropriate volume based on Blood-Pack Unit used.Note: The volume of anticoagulant is sufficient for the blood collection indicated on Blood-Pack Unit ± 10%. 11.Release the pressure on the donor’s arm as appropriate.Precaution: Do not proceed with the remaining steps until the entire whole blood unit is collected. 12.To avoid possible contamination of the whole blood unit, before filling whole blood sample tubes, hermetically seal the donor tubing near the Y-Sampling Site on the side leading to the primary container using a metal clip or appropriate alternate method.Precaution: Complete steps 13 - 22 within approximately 4 minutes after sealing the donor tubing to avoid possible clot formation in the tubing. 13.To collect samples, insert the access device by pushing firmly into the Y-Sampling Site until the membrane seal is penetrated (see Figure 2).Note: If the access device is assembled such that the outer barrel is screwed onto the Luer, make sure to rotate clockwise upon insertion to avoid barrel detaching from Luer. 14.Open the cap on the access device (if applicable). 15.Directly align the vacuum sample tube with the internal needle in the access device. Insert vacuum sample tube into device until the stopper is punctured. 16.Allow vacuum sample tube to fill with blood then remove from the access device. 17.Repeat steps 15 and 16 until the desired number of vacuum sample tubes have been filled.Notes: •If the access device needs to be replaced, use a hemostat to clamp the tubing between the needle and the Y-Sampling Site. Then, grasp base of Sampling Site with one hand and pull the access device out with the other hand. Firmly insert the new access device. Remove hemostat and continue sampling. •If the access device is assembled such that the outer barrel is screwed onto the Luer, make sure to rotate clockwise upon removal to avoid barrel detaching from Luer. •The access device can only be replaced one time.Precaution: When replacing the access device, be careful to avoid contact with any blood droplets on the Luer or Sampling Site. Discard used access device appropriately. 18.Release remaining pressure on donor’s arm. 19.If desired, apply hemostat to donor tubing between needle and Y-Sampling Site.20.Withdrawal of Needle (see Figure 3)Precaution: The needle guard must be held stationary while the needle is withdrawn into it.a)Place folded sterile gauze over puncture site and hold in place with finger tip without exerting pressure.b)Hold sides of needle guard near the front, between the index finger and thumb. Pull the tubing smoothly until the needle is locked into the needle guard.c)Confirm the needle lock by: •Listen for the 2nd “click” as the needle is drawn into the needle guard. •Ensure the tubing cannot be pulled through the needle guard. 21.Remove and discard the Y-Sampling Site and needle guard into an appropriate biohazardous waste container following established procedures. If donor tubing is also to be discarded, hermetically seal donor tubing directly above the primary container and remove.Note: Step 22 may be performed prior to step 21 if desired. 22.If the donor tubing is not hermetically sealed directly above the primary container, then strip the blood from the remaining donor tubing into the primary container. Mix and allow tubing to refill; repeat once.Component Preparation:Notes: •If a platelet concentrate is to be prepared, it should be separated within 8 hours after blood collection. •Fresh Frozen Plasma should be separated from the Red Blood Cells and placed in the freezer at -18°C or colder within 8 hours after blood collection. •Adsol Red Cell Preservation Solution should be added to the Red Blood Cells immediately after the removal of plasma. Preparation of AS-1 Red Blood Cells may vary depending on processing option selected:a)Within 8 hours of blood collection if whole blood is held at ambient temperature.b)Within 3 days of blood collection if whole blood is refrigerated. 23.At the appropriate time, prepare the Blood-Pack Unit with Integral Filter for centrifugation.Note: It is important to pack the filter properly in the centrifuge cup to avoid damage to the filter during centrifugation. Do not place the filter, breakaway cannula or check valve in the lower half of the centrifuge cup.Note: Steps 24 through 30 provide one method for centrifuge cup loading. 24.Thoroughly mix the primary container end over end. 25.Place the filter unit on a work surface, and arrange the containers with the bottoms of the containers (hanger edge) closer to the front of the work surface and the tops of the containers (tab edge) farther away. 26.Place the empty container (or Adsol Red Cell Preservation Solution container, as desired) on top of the primary container. Orient the breakaway cannula and check valve portion of the filter assembly near the top of this container. Place the filter on the top to middle (upper half) of container. Note: Do not place filter, breakaway cannula or check valve on lower half of the container. 27.Place one of the remaining containers on top of the filter. Gather all the tubing and place it on top of this container. 28.Place the remaining container on top of the stack. The label side may be turned outward from the stack to facilitate sliding the stack into the cup. Align the bottoms (hanger edge) of the containers together and keep the filter aligned as before.Note: Steps 26-28 may be performed in the reverse order. The specific stacking order and methodology may also vary depending on the workstation setup and centrifuge equipment used. 29.Holding the bundle of containers by the sides of the stack, squeeze the bundle firmly and slide it into the centrifuge cup.Note: Ensure that the filter, breakaway cannula and check valve do not move to the lower portion of the centrifuge cup when loading.Note: The tabs of the containers may be tucked inward to avoid the unit from interfering with free movement of the cup. 30.Verify that the top edge of the filter is level with, or below, the top of the centrifuge cup. Any excess tubing should be pushed down into the centrifuge cup. 31.Perform centrifugation according to center procedures. 32.Following centrifugation, remove containers from the centrifuge cup taking care not to disturb the Red Blood Cell / plasma interface. 33.Place primary container in a plasma extractor and apply pressure. Open the cannula on the top of the primary container to transfer plasma into the empty Transfer Pack container. 34.When the desired amount of plasma has been removed, clamp the tubing between the plasma container and the Y-connector closest to the plasma container and release pressure on the primary container. 35.Suspend the Adsol Red Cell Preservation Solution container, open the cannula on the Adsol Solution container and drain the contents into the primary container of the CPD Red Blood Cells. Clamp the Adsol Red Cell Preservation Solution tubing. 36.Seal the segment tubing in three places between the Y-connectors (leaving segments connected to the primary container). Cut the middle seal, being careful to avoid fluid splatter.Note: Refer to separate direction sheet for recommendation for handling and archiving segments. 37.Mix the Adsol Red Cell Preservation Solution and red cells thoroughly.Filtration Procedure:Precaution: Red blood cell products collected from certain donors may have extended filtration times and the potential for ineffective filtration and leukoreduction. 38.Mix unfiltered AS-1 Red Blood Cells thoroughly. Invert the unfiltered AS-1 Red Blood Cells and hang the filter set such that the filter remains vertical. To achieve maximum flow rate, allow the set to hang to full length.Note: The storage container must remain below the level of the filter during filtration. 39.Inspect all tubing to ensure it hangs freely without kinks. 40.Break the in-line cannula above the filter to start filtration.Note: Manual or mechanical pressure should not be used to increase the flow rate through the filter.Note: Tubing below the filter should not be stripped at any time during the filtration process.Note: If filtration of red cells is initiated at ambient temperature, the filtration process can be completed at either ambient or refrigerated temperature prior to storing the red cells between 1 and 6°C. However, for optimal filtration time, it is recommended to complete the filtration at ambient temperature.41.As the filtered red cell storage container is filling, or when flow stops, clamp or pinch the tubing below the filter to occlude flow. 42.Gently squeeze the filtered red cell storage container to expel air through the vent line until the red cells reach the one way valve. Remove the clamp or release the tubing to resume red cell flow through the filter. When filtration is complete, air can be observed in the inlet side of the filter. 43.Hermetically seal and detach the tubing below the filter. Also, hermetically seal and detach the vent line between the one way valve and the top donor segment number. 44.Make segments from the vent line tubing and leave segments attached to the filtered red cell storage container. (QC samples may be prepared by thoroughly mixing the filtered red cells and stripping this tubing.) 45.Store the AS-1 Red Blood Cells, Leukocytes Reduced between 1 and 6°C. 46.Infuse the red cells within 42 days of collection. Warning: Failure to achieve closed system processing conditions negates the extended storage claim and the red blood cell product must be transfused within 24 hours.Baxter Healthcare CorporationDeerfield, IL 60015 USAMade in USA07-19-55-442Iss. January 2008FENWAL, BLOOD-PACK, TRANSFER PACK, ADSOL, and FLEX-EXCEL are trademarks of Fenwal, Inc.Baxter is a registered trademark of Baxter International, Inc.Sepacell is a registered trademark of Asahi Kasei Medical Co., Ltd.DonorCare is a trademark of ITL Corporation.

Recommendation For Handling And Archiving Segments From Blood-Pack Unit With Integral Red Cell Filter

  • Rx onlyThis Product Contains Dry Natural Rubber.The Blood-Pack unit with Integral Filter is manufactured with two different sets of segment numbers as shown below. The use of two sets of numbers requires special processing in order to assure component traceability. The following process is one suggested method which may be implemented in the blood processing lab but not at the collection site.1.Collect whole blood unit and prepare AS-1 Red Blood Cells as described in the Directions for Use.2.To disconnect the plasma and/or platelet packs from the red cells in the primary container, heat seal the plasma line tubing using three seals at site A as shown in the figure below. Cut through the middle seal and disconnect the packs, making sure that the donor segments between the red cell container and site A stay with the red cells in the primary container.3.Filter the AS-1 Red Blood Cells as described in the Directions for Use. Heat seal the tubing on the filtered red cell storage pack at sites B and C, as described in Directions for Use.4.Prepare donor segments from the “X” and “Y” numbered tubing.5.Attach a donor’s ID number to the donor segments at site A and site C. Disconnect these two different donor segments and store together as retention samples for traceability.Baxter Healthcare CorporationDeerfield, IL 60015 USAMade in USA07-19-44-337Iss. August 2004Baxter, Blood-Pack, Transfer Pack and Adsol are trademarks of Baxter International Inc.

Package/Label Display Panel

  • Code 4R1586 10 UnitsBaxterAnticoagulant Citrate Phosphate Dextrose Solution, USP (CPD) Blood-Pack™ Unit; Transfer Pack™ Container with Adsol™ Red Cell Preservation Solution; Integral Sepacell Flex-Excel™ Red Cell Leukocyte Reduction FilterTriple For the Collection and Processing of 500 mL BloodY-Sampling Site, DonorCare Needle Guard, 16 ga. Ultra Thin Wall NeedleEach unit consists of a PL 2209 Plastic primary container with 70 mL of CPD solution containing 1.84 g Sodium Citrate (dihydrate) USP, 1.78 g Dextrose (monohydrate) USP, 209 mg Citric Acid (anhydrous) USP, 155 mg Monobasic Sodium Phosphate (monohydrate) USP, pH may have been adjusted with sodium hydroxide; one 400 mL PL 2209 Plastic Satellite Container with 110 mL of Adsol Red Cell Preservation Solution containing 2.42 g Dextrose (monohydrate) USP, 990 mg Sodium Chloride USP, 825 mg Mannitol USP, 30 mg Adenine USP; one empty 400 mL PL 2209 Plastic Transfer Pack Container; one Integral Sepacell Flex-Excel Red Cell Leukocyte Reduction Filter and one empty 450 mL PL 2209 Plastic Transfer Pack Container for the storage of AS-1 Red Blood Cells, Leukocytes Reduced.Sterile, nonpyrogenic fluid pathSee instructions for use.Store at room temperature. •Open pouch by tearing across at notch. •Unused units in open foil pouch may be kept up to 60 days by folding and securing open end of foil pouch to prevent possible loss of moisture. •Direct handling of product surfaces prior to extended storage in the foil pouch, may result in mold growth. •Units removed from the foil pouch must be used within 4 days (96 hours). Units out of the foil pouch for longer than 4 days must be discarded.Rx onlyU.S. Pat. Nos.: 5,314,421; 5,372,143; 5,507,525; 5,055,609; 6,132,413; 6,367,634; 6,422,397; 6,688,476; 6,745,902; pat. pend.FENWAL, BLOOD-PACK, ADSOL, PL 2209, TRANSFER PACK and FLEX-EXCEL are trademarks of Fenwal, Inc.Baxter is a trademark of Baxter International Inc.Sepacell is a trademark of Asahi Kasei Medical Co., Ltd.DonorCare is a trademark of ITL Corporation.Baxter Healthcare CorporationDeerfield, IL 60015 USAMade in USA07-28-55-566    01/2008

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