NDC 0942-6501 Adsol Red Cell Preservation Solution System In Plastic Container (pl 146 Plastic)

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

NDC Product Code 0942-6501

NDC CODE: 0942-6501

Proprietary Name: Adsol Red Cell Preservation Solution System In Plastic Container (pl 146 Plastic) 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.
    • 0942-6501 - Adsol Red Cell Preservation Solution System In Plastic Container (pl 146 Plastic)

NDC 0942-6501-03

Package Description: 1 KIT in 1 KIT * 63 mL in 1 BAG * 100 mL in 1 BAG

NDC Product Information

Adsol Red Cell Preservation Solution System In Plastic Container (pl 146 Plastic) with NDC 0942-6501 is a a human prescription drug product labeled by Fenwal, Inc.. The generic name of Adsol Red Cell Preservation Solution System In Plastic Container (pl 146 Plastic) 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.

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: BN811104 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: 03-04-2011 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: 12-31-2020 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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Adsol Red Cell Preservation Solution System In Plastic Container (pl 146 Plastic) 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

Instructions For Blood Collection Using (Cpd) Blood-Pack™ Unit With An Integrally Attached Container Of Adsol™ Red Cell Preservation Solution.

  • Rx OnlyBLOOD-PACK™ unit for the collection, processing and/or storage of blood or blood components.Contains Y-Sampling SiteUse aseptic technique.CPD formula: Each 63 mL of CPD solution contains: 1.66 g Sodium citrate (dihydrate) USP; 1.61 g Dextrose (monohydrate) USP; 188 mg Citric acid (anhydrous) USP; 140 mg Monobasic sodium phosphate (monohydrate) USP; Water for Injection USP to 63 mL ADSOL™ formula: Each 100 mL of ADSOL solution contains: 900 mg Sodium chloride USP; 2.20 g Dextrose monohydrate USP; 27.0 mg Adenine USP; 750 mg Mannitol USP; Water for Injection USP to 100 mL.Caution: Do not use unless the solutions are clear.1.Identify BLOOD-PACK unit using appropriate donor identification system.2.Adjust donor scale to desired collection weight/volume.3.Suspend primary container from donor scale as far as possible below donor arm and clamp donor tubing with hemostat.4.Apply pressure to donor’s arm and disinfect site of venipuncture.5.If blood pressure cuff is used, inflate to approximately 60 mm Hg.6.Remove needle cover per instructions below:a)Hold the needle hub upwards. With the other hand, grasp the base of the needle cover (Figure 1), twist approximately 1/4 turn to break tamper evident seal (Figure 2).b)Remove needle cover (Figure 3), be careful not to drag cover across the needle point (Figure 4).7.Perform venipuncture, appropriately secure donor needle and/or tubing and release hemostat.8.Mix blood and anticoagulant at several intervals during collection and immediately after collection.9.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%.10.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.11.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 12 - 20 within approximately 4 minutes after sealing the donor tubing to avoid possible clot formation in the tubing.12.To collect samples, insert the access device by pushing firmly into the Y-Sampling Site until the membrane seal is penetrated (see Figure 5).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.13.Open the cap on the access device (if applicable).14.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.15.Allow vacuum sample tube to fill with blood then remove from the access device.16.Repeat steps 14 and 15 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.17.Release remaining pressure on donor’s arm.18.If desired, apply hemostat to donor tubing between needle and Y-Sampling Site.19.Withdraw the needle.20.Preparation of AS-1 Red Blood Cells may vary depending on processing option selected:a)After removal of plasma from freshly collected blood.b)Within 8 hours of blood collection if whole blood is held at ambient temperature.c)Within 3 days of collection if blood is refrigerated immediately following collection.21.Centrifuge primary and secondary containers to prepare CPD Red Blood Cells.22.Place primary container in plasma extractor and express plasma into empty TRANSFER-PACK™ container by releasing pressure plate and breaking cannula. (To break cannula, grasp the base of the cannula with one hand. With the other hand grasp the top of the cannula and bend 90° in one direction then 180° in opposite direction (Figure 6)).23.When desired amount of plasma has been removed, clamp tubing between Y and plasma container.24.Suspend ADSOL™ red cell preservation solution container, break cannula (Figure 6) and drain contents into primary container of CPD Red Blood Cells. Clamp tubing.25.Seal transfer tubing in three places near primary container and cut the middle seal, being careful to avoid fluid splatter. For Double BLOOD-PACK unit codes, discard ADSOL solution container. For other ADSOL codes, the empty solution container may now be used as a TRANSFER-PACK container for further component preparation.26.Mix ADSOL solution and red cells thoroughly.27.Store suspended AS-1 Red Blood Cells between 1 and 6°C.28.Infuse AS-1 Red Blood Cells within 42 days of collection.For further processing, use standard component processing and storage techniques.Dispose of containers and materials into appropriate biohazardous waste containers following established procedures.Single use only. Sterile, non-pyrogenic fluid path. Store at Controlled Room Temperature.USP Definition of “Controlled Room Temperature”United States Pharmacopeia, General Notices.United States Pharmacopeial Convention, Inc.12601 Twinbrook Parkway, Rockville, MDManufactured by:Fenwal International, Inc.Road 357, Km. 0.8Maricao, PR 00606Made in USAFENWAL, BLOOD-PACK, ADSOL and TRANSFER-PACK are trademarks of Fenwal, Inc.07-19-05-702    REV: A 03/2011© 2011 Fenwal, Inc. All rights reserved.

Package/Label Display Panel

N4R6346 6 UnitsFenwal™Triple BLOOD-PACK™ Unit CPD/ADSOL™PL 146PL 1240Plastic Rx onlyTriple BLOOD-PACK unit consisting of a primary pack containing 63 mL of CPD anticoagulant solution for collection of 450 mL of blood, one TRANSFER-PACK containing 100 mL of ADSOL solution and one TRANSFER-PACK without solution. 16 gauge needle.See instructions for use. Sterile, non-pyrogenic fluid path. Steam sterilized. Single use only. Do not vent. Do not use if there is any visible sign of deterioration. Dispose of container appropriately. Store at Controlled Room Temperature (refer to direction insert). Unused packs in open pouches may be kept 60 days by folding and securing end of pouch, to prevent loss of moisture.Direct handling of product surfaces prior to extended storage in the foil pack 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.CPD formula: Each 63 mL of CPD solution contains: 1.66 g, Sodium citrate (dihydrate), USP, 1.61 g Dextrose (monohydrate), USP, 188 mg Citric acid (anhydrous), USP, 140 mg Monobasic sodium phosphate (monohydrate), USP. Water for Injection USP to 63 mLADSOL formula: Sodium chloride 900 mg, USP, Dextrose monohydrate 2.20 g, USP, Adenine 27.0 mg, USP, Mannitol 750 mg, USP. Water for Injection USP to 100 mL.Manufactured by:Fenwal International, Inc.Road 357, Km. 0.8Maricao, PR 00606Made in USA07-28-05-404    REV: AImported and distributed in Thailand by:Fenwal (Thailand) Ltd.17th Fl. Thanapoom Tower,1550 New Petchburi Rd., MakasanRajthevi, Bangkok 10400ThailandDate of opening of pouch:FENWAL, BLOOD-PACK, TRANSFER-PACK and ADSOL are trademarks of Fenwal, Inc.Lot No.:Exp. date:

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