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Who uses this page: blood bank and transfusion service staff, laboratory buyers and students who need to know what a blood bag is, how the common configurations differ, and what the federal rules say about the container, its anticoagulant and its label. This page describes products and general use; it is not medical advice.
What a blood bag is
A blood bag, also called a blood collection bag, is a sterile plastic container used to collect, store or transfer blood and blood components. In the United States, FDA regulates it as “an empty container for the collection and processing of blood and blood components” under 21 CFR 864.9100: “an empty plastic bag or plastic or glass bottle used to collect, store, or transfer blood and blood components for further processing.” It is a Class II device (performance standards), FDA product code KSR.
The bag does not do anything by itself. It is one part of a blood collection, processing and storage system, and the dating periods that apply to the blood it holds depend on the anticoagulant in that system.
How a blood bag is built
A collection set is a primary bag joined by tubing to a needle and, in multiple sets, to one or more satellite bags. The primary bag arrives holding a measured volume of anticoagulant solution. Satellite bags are empty and are used for components that are separated from the collected unit.
The Terumo TERUFLEX Blood Bag System with CPDA-1 labeling is a documented example. Its primary bag has a nominal capacity of 600 mL and contains 63 mL of CPDA-1 for an intended collection of 450 mL (plus or minus 10%). The 63 mL of CPDA-1 contains 188 mg citric acid, 1.66 g sodium citrate, 140 mg monobasic sodium phosphate, 2.01 g dextrose and 17.3 mg adenine. The set has a 16-gauge, 1.5 in needle with a cover. The bags are made of PVC with a DEHP plasticizer, contain no natural rubber latex, and ship with an oxygen absorber packet that is not to be opened.
Types: single, double and triple sets
Sets are named by how many bags they contain. The table shows one manufacturer’s labeling (Terumo TERUFLEX CPDA-1); other manufacturers’ sets may differ.
| Set (Terumo TERUFLEX CPDA-1) | Bags | Key difference |
|---|---|---|
| Single | Primary bag, 450 mL collection, 63 mL CPDA-1 | Collection only; no satellite bag |
| Double | Primary bag plus one empty satellite bag (nominal 400 mL) | Adds one bag for a separated component |
| Triple | Primary bag, empty satellite bag (nominal 400 mL), empty XT-612 5-day platelet bag (nominal 500 mL) | Adds a bag labeled for platelets stored up to 5 days at 20-24 C |
Anticoagulant and storage dating
21 CFR 610.53 sets dating periods for blood and components unless the instructions for use of the FDA-approved or cleared collection, processing and storage system specify a different period. For two common products the dating depends on the anticoagulant or additive solution:
| Product | Anticoagulant or solution | Storage | Dating period from collection |
|---|---|---|---|
| Whole Blood | ACD, CPD or CP2D | 1-6 C | 21 days |
| Whole Blood | CPDA-1 | 1-6 C | 35 days |
| Red Blood Cells | ACD, CPD or CP2D | 1-6 C | 21 days |
| Red Blood Cells | CPDA-1 | 1-6 C | 35 days |
| Platelets | Not listed in the table | 20-24 C | 5 days |
The Terumo CPDA-1 labeling is consistent with the CPDA-1 rows: red blood cells or whole blood at 1-6 C for up to 35 days, and platelets at 20-24 C for up to 5 days in the XT-612 bag.
Label requirements
Under 21 CFR 606.121, the container label must include the proper name of the product, the manufacturer’s name, address and facility identifier, the donor or lot number, the expiration date, and the recommended storage temperature in degrees Celsius. For Whole Blood the label also gives the volume (plus or minus 10%). A label applied by the collecting facility must not be removed, altered or obscured, except to indicate the proper product name.
How to choose
These criteria come from the regulations and labeling cited below, not from a ranking:
- Anticoagulant. It determines the dating period (21 days for ACD, CPD or CP2D; 35 days for CPDA-1 whole blood and red cells), unless the system’s instructions for use specify otherwise.
- Configuration. A set with a platelet bag, such as the triple set above, is labeled for platelet storage; a single set has no satellite bag.
- Regulatory status. The blood collection, processing and storage system must be approved or cleared by FDA for the use, and the empty container itself is a Class II device.
- Material. The labeling states whether the set contains DEHP and natural rubber latex; the Terumo example contains DEHP and no latex.
Safe use and handling basics
- The Terumo labeling states the set is for single use only.
- The Terumo labeling calls for inspecting the set for leaks and states that it is not to be used unless the solutions are clear and free from particulates.
- The labeling states a blood collection bag is not intended for direct intravenous infusion.
- The labeling gives unused-bag storage as at room temperature (15-30 C), away from heat and sunlight, and protected from freezing. After the outer overwrap is opened, unused bags are good for 96 hours at room temperature, or 30 days if the cover film is resealed with tape.
- The labeling notes that handling blood carries possible exposure to infectious agents, so adequate precautions apply at all times.
Common mistakes
- Applying one dating period to every bag. The period depends on the anticoagulant and the system’s instructions.
- Treating a blood bag as a general specimen container. Specimen collection items are a different product class; see specimen containers.
- Confusing the bag with the tubing that carries blood to or from it; see blood tubing.
- Removing or covering the collecting facility’s label, which 21 CFR 606.121 prohibits except to indicate the proper product name.
FAQ
What is a blood bag?
A sterile plastic container, usually with an anticoagulant solution, used to collect, store or transfer blood and blood components. FDA classifies the empty container as a Class II device under 21 CFR 864.9100.
What is a blood collection bag?
The same product. FDA’s wording is “container for the collection and processing of blood and blood components”; “blood bag” and “blood collection bag” describe the primary bag of a collection set.
How long can blood be stored in a blood bag?
It depends on the anticoagulant: 21 days for whole blood with ACD, CPD or CP2D, and 35 days with CPDA-1 (21 CFR 610.53). Platelets stored at 20-24 C have 5 days.
What is in a blood bag set?
A primary bag with anticoagulant, a needle, tubing and, in double and triple sets, empty satellite bags. In the Terumo CPDA-1 example the primary bag holds 63 mL of anticoagulant for a 450 mL collection.
Related reading: blood bank and transfusion service supply checklist, platelet agitator vs platelet incubator, blood bank refrigerator vs general-purpose refrigerator.
Sources
Date checked for all sources: 2026-10-30.
- 21 CFR 864.9100, Empty container for the collection and processing of blood and blood components: https://www.law.cornell.edu/cfr/text/21/864.9100
- openFDA device classification, product code KSR: https://api.fda.gov/device/classification.json?search=regulation_number:864.9100
- 21 CFR 610.53, Dating periods for licensed biological products: https://www.law.cornell.edu/cfr/text/21/610.53
- 21 CFR 606.121, Container label: https://www.law.cornell.edu/cfr/text/21/606.121
- Terumo TERUFLEX Blood Bag System CPDA-1 labeling, mirrored on Guideline Central: https://www.guidelinecentral.com/drug/14b53ad8-3e44-401e-bd9b-ca81848a6b18/teruflex_blood_bag_system_anticoagulant_citrate_phosphate_dextrose_adenine_(cpda-1/
