NDC 0942-6502 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 0942-6502

NDC Code: 0942-6502

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.
    • 0942-6502 - Adsol Red Cell Preservation Solution System In Plastic Container (pl 146 Plastic)

NDC 0942-6502-04

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 0942-6502 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: 01-11-2011 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: 12-31-2019 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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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 Optipac™ Unit With An Integrally Attached Container Of Adsol™ Red Cell Preservation Solution

  • Rx Only Opti-System Use aseptic techniqueCaution: Do not use unless the solutions are clear.1.Identify BLOOD-PACK™ OPTIPAC™ 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, or use tourniquet as applicable.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 labeled volume of blood. Anticoagulant volume is sufficient for labeled volume ± 10%.10.Apply hemostat to donor tubing.11.If it is necessary, obtain whole anticoagulated blood samples for typing or crossmatching by returning donor tubing blood to the primary bag, mixing and allowing tubing to refill. Repeat once. Seal donor tubing at the desired intervals in order to obtain the desired total blood samples.12.Centrifuge primary and secondary bags in order to prepare CPD Red Blood Cells.13.Refer to the OPTIPRESS™ Blood Components Automated Extractor User Manual, in order to prepare the components.14.After separation, seal transfer tubing in three places near the primary bag and cut middle seal taking care to avoid fluid splatter.NOTE: In OPTIPAC Quadruple BLOOD-PACK unit, the empty transfer unit may be used for preparation of other components.15.Fill empty tubing of OPTIPAC AS-1 for red blood cells by stripping the tubing and mixing the AS-1 containter, twice, in order to ensure that the tubing is correctly filled. Seal on "X" marks on tubing in order to obtain red blood cells samples.16.Mix Adsol Solution and red cells thoroughly.17.Store suspended Red Blood Cells between 1 and 6 °C.For further processing, use standard techniques for component processing.Sterile, non-pyrogenic fluid path. Sterilized by steam. Single use only. Dispose of container appropriately.Store at Controlled Room TemperatureUSP 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 USA07-19-05-015    REV: A07/2010Imported and distributed in Indonesia by:PT.Medquest Jaya GlobalMenara Salemba 6th FloorJl.Salemba Raya Kav 5-5AJakarta-Indonesia 10440Reg. No.: DEPKES RI AKL 20209902359Imported and distributed in Thailand by:Fenwal (Thailand) Ltd.17th Fl. Thanapoom Tower1550 New Petchburi Rd., MakasanRajthevi, Bangkok 10400ThailandReg. No.:Imported and distributed in Philippines by:Medlink MarketingUnit 404 Vicar’s Building,No.31 Visayas Ave.,Vasra, Quezon City 1100PhilippinesReg. No.: DVR-5805– ManufacturerFENWAL, ADSOL, BLOOD-PACK, OPTIPAC and OPTIPRESS are trademarks of Fenwal, Inc.© 2010 Fenwal, Inc. All rights reserved.

Package/Label Display Panel

Code A4R7703 5 UnitsFenwal™Quadruple BLOOD-PACK™ OPTIPAC™ Unit CPD/ADSOL™ OPTI-SYSTEM™Rx onlyQuadruple BLOOD-PACK OPTIPAC 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 two TRANSFER-PACK containers without solution. 16 gauge needle.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 mLEach 100 mL of ADSOL solution contains: 2.20 g Dextrose (monohydrate), USP - 900 mg Sodium Chloride (monohydrate,) USP - 750 mg Mannitol, USP - 27.0 mg Adenine, USP. Water for injection USP to 100 mL.See instructions for use. Sterile, non-pyrogenic fluid path. Steam sterilized. Single use only. Do not vent. Do not use if there is visible evidence of deterioration. Dispose of container properly.Store at Controlled Room Temperature(refer to direction insert).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.Manufactured by:Fenwal International, Inc.Road 357, Km. 0.8Maricao, PR 00606Made in USAImported and distributed in Thailand by:Fenwal (Thailand) Ltd.17th Fl. Thanapoom Tower1550 New Petchburi Rd., MakasanRajthevi, Bangkok 10400ThailandImported and distributed in Indonesia by:PT.Medquest Jaya GlobalMenara Salemba 6th FloorJl.Salemba Raya Kav 5-5AJakarta-Indonesia 10440Reg. No.: DEPKES RI AKL 20209902359FENWAL, BLOOD-PACK, ADSOL, OPTIPAC and OPTI-SYSTEM are trademarks of Fenwal, Inc.07-28-05-406    REV: ALot No.:Exp. Date:

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