Fresh Whole Blood Recipient Set 80-801-R

GUDID M68980801R020

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.

Safeguard US Operating, LLC

Blood transfusion set, non-exchange
Primary Device IDM68980801R020
NIH Device Record Key15bc21b4-9487-44ba-a892-983b8455b741
Commercial Distribution Discontinuation2018-05-04
Commercial Distribution StatusNot in Commercial Distribution
Brand NameFresh Whole Blood Recipient Set
Version Model Number2
Catalog Number80-801-R
Company DUNS118492643
Company NameSafeguard US Operating, LLC
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kittrue
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone855-428-6074
Emailfulfillment@combatmedicalsystems.com
Phone855-428-6074
Emailfulfillment@combatmedicalsystems.com
Phone855-428-6074
Emailfulfillment@combatmedicalsystems.com
Phone855-428-6074
Emailfulfillment@combatmedicalsystems.com
Phone855-428-6074
Emailfulfillment@combatmedicalsystems.com
Phone855-428-6074
Emailfulfillment@combatmedicalsystems.com
Phone855-428-6074
Emailfulfillment@combatmedicalsystems.com
Phone855-428-6074
Emailfulfillment@combatmedicalsystems.com
Phone855-428-6074
Emailfulfillment@combatmedicalsystems.com
Phone855-428-6074
Emailfulfillment@combatmedicalsystems.com
Phone855-428-6074
Emailfulfillment@combatmedicalsystems.com
Phone855-428-6074
Emailfulfillment@combatmedicalsystems.com
Phone855-428-6074
Emailfulfillment@combatmedicalsystems.com
Phone855-428-6074
Emailfulfillment@combatmedicalsystems.com
Phone855-428-6074
Emailfulfillment@combatmedicalsystems.com
Phone855-428-6074
Emailfulfillment@combatmedicalsystems.com

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCM68980801R020 [Primary]

FDA Product Code

BRZSet, Blood Transfusion

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number5
Public Version Date2022-04-12
Device Publish Date2017-08-04

On-Brand Devices [Fresh Whole Blood Recipient Set]

M68980801R020Designed for missions in the most remote and austere environments, the Fresh Whole Blood Transfu
M68980801R01Designed for missions in the most remote and austere environments, the Fresh Whole Blood Transfu
M68980801R070FRESH WHOLE BLOOD RECIPIENT SET Constricting Band (18"x1") 1 ea Gauze Sponge
M68980801R080FRESH WHOLE BLOOD RECIPIENT SET Constricting Band (18"x1") 1 ea Gauze Sponge
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