Fenwal BLOOD-PACK™ Single Blood Pack Unit, CPDA-1, 450 mL, Y-Sampling Site, CS/72EA is a prescription-use blood-collection system designed for professional collection and processing of 450 mL of whole blood. Each primary container includes 63 mL of CPDA-1 anticoagulant solution and a sterile, non-pyrogenic fluid path.
The single-chamber configuration incorporates a Y-sampling site for collection of unanticoagulated whole-blood samples for laboratory testing and a 16-gauge ultra-thin-wall Fenwal HighFlo collection needle. Twelve units are packaged per pouch, with six pouches supplied in each 72-unit case.
Key Features
| Blood Collection System | Sampling & Collection | Professional Packaging |
|---|
| 450 mL primary blood container | Y-sampling site | 12 units per pouch |
| 63 mL CPDA-1 anticoagulant | 16 ga ultra-thin-wall collection needle | 6 pouches per case |
| Single-chamber configuration | HighFlo needle design | 72 total units per case |
| Sterile fluid path | Designed for blood collection and processing | Prescription-use product |
Specifications
| Attribute | Details | Attribute | Details |
|---|
| Brand | Fenwal BLOOD-PACK™ | Manufacturer | Fenwal / Fresenius Kabi |
| MPN | 4R3611 | NDC | 09429-0394-01 |
| Product Type | Single Blood Pack Unit | Application | Blood Collection and Processing |
| Configuration | Single Chamber | Primary Container Capacity | 450 mL |
| Anticoagulant | CPDA-1 | Anticoagulant Volume | 63 mL |
| Sampling System | Y-Sampling Site | Needle Size | 16 Gauge |
| Needle Design | Ultra-Thin-Wall HighFlo | Administration Method | Not for Administration |
| Material | Plastic | DEHP Indicator | DEHP |
| Fluid Path | Sterile | Pyrogen Status | Non-Pyrogenic Fluid Path |
| Prescription Status | Rx Only | Usage | Single Use |
| Inner Packaging | 12 Units per Pouch | Pouches per Case | 6 |
| Total Units per Case | 72 | Packaging | CS/6PK/12EA |
| Minimum Selling Unit | CS | Authorized EA Sales | No |
| BAA Compliant | No | TAA Compliant | No |
| UNSPSC | 41104106 | Country of Origin | Not Verified |
CPDA-1 Solution per Unit
| Component | Approximate Quantity |
|---|
| Dextrose, Monohydrate USP | 2 g |
| Sodium Citrate, Dihydrate USP | 1.66 g |
| Citric Acid, Anhydrous USP | 188 mg |
| Monobasic Sodium Phosphate, Monohydrate USP | 140 mg |
| Adenine USP | 17.3 mg |
| Total CPDA-1 Solution | 63 mL |
Warnings
| Professional / Prescription Use | Sterility & Collection | Storage & Package Control |
|---|
| Rx only; intended for professional blood-collection and processing programs | Use aseptic technique during blood collection | Store at controlled room temperature |
| Not intended for administration of the supplied CPDA-1 solution directly to a patient | Do not use unless the anticoagulant solution is clear | Protect from freezing |
| Follow the complete blood-collection instructions and donor-management protocol | Do not use if the fluid path, tubing, needle, or container is damaged | Avoid excessive heat |
| Use an appropriate donor identification system | Single-use product; do not reuse | Verify expiration dating before dispensing or institutional bidding |
| Confirm the desired collection weight before beginning collection | Inspect packaging before opening | Follow labeled time limits after opening the protective foil pouch |
| Y-sampling procedures should follow applicable laboratory and blood-bank protocols | Dispose of used needles in an approved sharps container | Discard units that exceed labeled out-of-pouch exposure limits |