Fresh Whole Blood Transfusion Set
Designed for missions in the most remote and austere environments, the Fresh Whole Blood Transfusion Set contains essential items to collect and transfuse fresh whole blood in a compact…
Designed for missions in the most remote and austere environments, the Fresh Whole Blood Transfusion Set contains essential items to collect and transfuse fresh whole blood in a compact sealed package. The set includes a donor module, blood collection bag and recipient module; that allow for donor collection and the ability to perform a transfusion procedure to the recipient. Product Description In remote areas and combat environments where definitive care may be too far away or inaccessible, transfusion of fresh whole blood may be the best option for management of hemorrhagic shock in casualties. Blood transfusions have been used successfully in military conflicts and other austere conditions to resuscitate trauma patients suffering from hemorrhagic shock. Developed with extensive research and feedback from the Armed Services Blood Program Office, the Fresh Whole Blood Transfusion Set contains everything needed to test for ABO/Rh compatibility and perform a fresh whole blood transfusion in a compact sealed package. NOTE: Only personnel trained in blood collection, transfusion, and management of transfusion reactions should use this set. Combat Capabilities • Easily administered • Simplifies training • Compact lightweight • Cost effective Product Attributes • 100% TAA compliant components (no waivers required) • Donor and recipient specific modules • Shelf life: 12 months • Made in USA Clinical Benefit • Assembled in FDA registered facility. • Adhesive blood bag label for recording donor information. • EldonCard™: ABO/Rh blood-typing card for simple, accurate, and fast results. • Re-sealable bag used to send all supplies back with casualty for retrospective testing. Specifications • NSN: 6515-01-657-4750 • PN: 80-801 • Single-use • 12-month Shelf Life o Does not contain natural rubber latex • Available Direct and GSA • 100% TAA Compliant • Made i
Who Else Makes It
Registered in Zhejiang.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Huzhou Junda Industry Co., Ltd. | Anji | Zhejiang | Contract manufacturer | 129 |
Record
| Listed by | Safeguard US Operating, LLC, United States |
|---|---|
| FDA product code | POQ |
| Device type | Blood Transfusion Kit |
| Device class | Class 2 |
| Regulation | 21 CFR 880.5440 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2022-08-09 |
| Record revised | 2022-04-12 (version 5) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Label carries | lot or batch number, expiry date |
| Storage | Special storage condition: Store at 20 to 25 degrees Celsius |
| Distribution end date | 2026-04-30 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 06 | In distribution | |
| 5 | Withdrawn | |
| 4 | Withdrawn | |
| 3 | Withdrawn | |
| 1 | Withdrawn | |
| 2 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Curaplex | Bound Tree Medical, LLC | 22 |
| NAR | North American Rescue, LLC. | 10 |
| Valkyrie Ltowb Collection Set | Safeguard US Operating, LLC | 8 |
| Valkyrie Ltowb Administration Set | Safeguard US Operating, LLC | 8 |
| Forward | Synchronis Medical LLC | 3 |
| TMM-Fbtk-FTX (Tactical Medical Module-Field Blood Transfusion Kit-Exercise) | Altitude Technologies Inc. | 1 |
| TMM-LTC (Tactical Medical Module – Low Titer Collection) | Altitude Technologies Inc. | 1 |
| Mojo RFR First Responder Set | Safeguard US Operating, LLC | 1 |
| Whole Blood Collection and Transfusion Kit | Altitude Technologies Inc. | 1 |
| TMM-FBT-SOF (Tactical Medical Module – Field Blood Transfusion-Spec Ops Forces) | Altitude Technologies Inc. | 1 |
| Project Lavoy Blood Kit | Altitude Technologies Inc. | 1 |
| TMM-LTA (Tactical Medical Module-Low Titer Administration) | Altitude Technologies Inc. | 1 |
Showing 12 of 14. All products under Blood Transfusion Kit
Recalls
5 of these are Class I. Class I is the FDA’s most serious grade: a reasonable probability of serious injury or death. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2020-12-23 | Class I | Process control | There is the potential of a bent or disconnected needle in one of the components of the convenience kits. | 531 units | 2024-07-09 |
| 2020-12-23 | Class I | Process control | There is the potential of a bent or disconnected needle in one of the components of the convenience kits. | 954 units | 2024-07-09 |
| 2020-12-23 | Class I | Process control | There is the potential of a bent or disconnected needle in one of the components of the convenience kits. | 1021 units | 2024-07-09 |
| 2020-12-23 | Class I | Process control | There is the potential of a bent or disconnected needle in one of the components of the convenience kits. | 27090 units | 2024-07-09 |
| 2020-12-23 | Class I | Process control | There is the potential of a bent or disconnected needle in one of the components of the convenience kits. | 953 units | 2024-07-09 |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.