Fresh Whole Blood Transfusion Set 80-801

GUDID M68980801040

FRESH WHOLE BLOOD TRANSFUSION SET Donor Set (PN 80-801-D) 1ea Recipient Set (PN 80-801-R) 1ea Instructions for Use 1ea

Safeguard US Operating, LLC

Blood transfusion set, non-exchange
Primary Device IDM68980801040
NIH Device Record Keye7a910de-49d6-4132-a821-ba6b5ad4aefc
Commercial Distribution Discontinuation2023-08-31
Commercial Distribution StatusNot in Commercial Distribution
Brand NameFresh Whole Blood Transfusion Set
Version Model Number4
Catalog Number80-801
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
Phone855-428-6074
Emailfulfillment@combatmedicalsystems.com

Operating and Storage Conditions

Special Storage Condition, SpecifyBetween 0 and 0 *Store at 20 to 25 degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store at 20 to 25 degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store at 20 to 25 degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store at 20 to 25 degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store at 20 to 25 degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store at 20 to 25 degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store at 20 to 25 degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store at 20 to 25 degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store at 20 to 25 degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store at 20 to 25 degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store at 20 to 25 degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store at 20 to 25 degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store at 20 to 25 degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store at 20 to 25 degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store at 20 to 25 degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store at 20 to 25 degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store at 20 to 25 degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCM68980801040 [Primary]

FDA Product Code

POQBlood Transfusion Kit

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2023-08-31
Device Publish Date2022-10-05

On-Brand Devices [Fresh Whole Blood Transfusion Set]

M689808010Designed for missions in the most remote and austere environments, the Fresh Whole Blood Transfu
M68980801050FRESH WHOLE BLOOD TRANSFUSION SET Donor Set (PN 80-801-D) 1ea Recipient Set (PN 80-80
M68980801040FRESH WHOLE BLOOD TRANSFUSION SET Donor Set (PN 80-801-D) 1ea Recipient Set (PN 80-80

© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.