NDC 0942-9001 Acd Blood-pack Units (pl 146 Plastic)

Anticoagulant Citrate Dextrose (acd)

NDC Product Code 0942-9001

NDC 0942-9001-01

Package Description: 67.5 mL in 1 BAG

NDC Product Information

Acd Blood-pack Units (pl 146 Plastic) with NDC 0942-9001 is a a human prescription drug product labeled by Fenwal, Inc.. The generic name of Acd Blood-pack Units (pl 146 Plastic) is anticoagulant citrate dextrose (acd). The product's dosage form is solution and is administered via intravenous form.

Labeler Name: Fenwal, Inc.

Dosage Form: Solution - A clear, homogeneous liquid1 dosage form that contains one or more chemical substances dissolved in a solvent or mixture of mutually miscible solvents.

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.

Acd Blood-pack Units (pl 146 Plastic) Active Ingredient(s)

What is the Active Ingredient(s) List?
This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.

  • DEXTROSE MONOHYDRATE 1.65 g/67.5mL
  • TRISODIUM CITRATE DIHYDRATE 1.48 g/67.5mL
  • ANHYDROUS CITRIC ACID 493 mg/67.5mL

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.

  • WATER (UNII: 059QF0KO0R)

Administration Route(s)

What are the Administration Route(s)?
The translation of the route code submitted by the firm, indicating route of administration.

  • Intravenous - Administration within or into a vein or veins.

Pharmacological Class(es)

What is a Pharmacological Class?
These are the reported pharmacological class categories corresponding to the SubstanceNames listed above.

  • Acidifying Activity - [MoA] (Mechanism of Action)
  • Calculi Dissolution Agent - [EPC] (Established Pharmacologic Class)
  • Anti-coagulant - [EPC] (Established Pharmacologic Class)
  • Decreased Coagulation Factor Activity - [PE] (Physiologic Effect)
  • Calcium Chelating Activity - [MoA] (Mechanism of Action)
  • Acidifying Activity - [MoA] (Mechanism of Action)
  • Calculi Dissolution Agent - [EPC] (Established Pharmacologic Class)
  • Anti-coagulant - [EPC] (Established Pharmacologic Class)
  • Decreased Coagulation Factor Activity - [PE] (Physiologic Effect)
  • Calcium Chelating Activity - [MoA] (Mechanism of Action)

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: BN160918 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: 03-01-2007 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’.

* Please review the disclaimer below.

Acd Blood-pack Units (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 Or Acd Single Blood-Pack™ Units

  • Integral Donor Tube (IDT)Rx onlyUse aseptic technique.Precaution: Do not use unless solution is clear.1.Identify Blood-Pack unit using appropriate donor identification system. Confirm that all numbered tubing of each Blood-Pack unit contains its own identical segment numbers.2.Adjust donor scale to desired collection weight.3.Position 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 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. Perform venipuncture, appropriately secure donor needle and/or tubing and release hemostat.7.Mix blood and anticoagulant at several intervals during collection and immediately after collection.8.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%.9.Apply hemostat to donor tube.10.As appropriate, release pressure on the donor’s arm, collect donor samples following established procedures and withdraw donor needle.Precaution: Use care to avoid accidental needle sticks. One of the Fenwal Needle Protector Systems may be used to reduce the risk of needle stick injury.11.Strip blood from donor tubing into container, mix and allow the tubing to refill; repeat once. Seal at X marks on donor tubing to provide numbered aliquots of anticoagulated blood for typing or crossmatching.12.Discard needle into an appropriate biohazardous waste container following established procedures.13.Store filled unit between 1 and 6° C.14.Infuse blood within 21 days of collection.Store at Controlled Room Temperature.USP Definition of “Controlled Room Temperature”United States Pharmacopeia, General Notices.United States Phramacopeial Convention, Inc.12601 Twinbrook Parkway, Rockville, MDFenwal and Blood-Pack are trademarks of Fenwal,Inc.Manufacturer© 2009 Fenwal, Inc. All rights reserved.Fenwal, Inc.Lake Zurich, IL 60047 USA1-800-933-6925Made in USA07-19-02-335 REV: A 02/2009

* Please review the disclaimer below.