Duns Number:118492643
Device Description: Designed for missions in the most remote and austere environments, the Fresh Whole Blood T 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 DescriptionIn 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 effectiveProduct Attributes• 100% TAA compliant components (no waivers required)• Donor and recipient specific modules• Shelf life: 12 months• Made in USAClinical 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.
Catalog Number
80-801
Brand Name
Fresh Whole Blood Transfusion Set
Version/Model Number
2
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
October 01, 2021
Issuing Agency
In HIBCC
MRI safety Status
Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)
-
Device labeled as "Not made with natural rubber latex"
-
For Single-Use
Yes
Prescription Use (Rx)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
POQ
Product Code Name
Blood Transfusion Kit
Public Device Record Key
640b1359-dfff-4eb5-bdf2-32a8b4ba8fe3
Public Version Date
April 12, 2022
Public Version Number
5
DI Record Publish Date
August 04, 2017
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
Device Class | Device Class Description | No of Devices |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 217 |
2 | A medical device with a moderate to high risk that requires special controls. | 48 |