Fresh Whole Blood Recipient Set 80-801-R

GUDID M68980801R060

FRESH WHOLE BLOOD RECIPIENT SET Constricting Band (18"x1") 1 ea Gauze Sponge (4"x4") 2ea Safety IV Catheter 16gx1.25" 1 ea Safety IV Catheter 18gx1.25" 1 ea IV Set "Y" - Type with Filter 1 ea Surgical Tape 1 ea Clear IV Dressing 1 ea ABO/Rh Screen (EldonCard) 1 ea Gloves (pair) 1 ea Alcohol Pads 2 ea Chlorhexidine Swap 1 ea Permanent Marker 1 ea SF 518 1 ea Instructions for Use 1 ea

COMBAT MEDICAL SYSTEMS, LLC

Blood transfusion set, non-exchange
Primary Device IDM68980801R060
NIH Device Record Keye578aaa7-592c-4776-be1c-0ca3d6f0823c
Commercial Distribution StatusIn Commercial Distribution
Brand NameFresh Whole Blood Recipient Set
Version Model Number06
Catalog Number80-801-R
Company DUNS809773968
Company NameCOMBAT MEDICAL SYSTEMS, 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
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
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
HIBCCM68980801R060 [Primary]

FDA Product Code

BRZSet, Blood Transfusion

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-10-11
Device Publish Date2021-10-02

On-Brand Devices [Fresh Whole Blood Recipient Set]

M68980801R030FRESH WHOLE BLOOD RECIPIENT SET Constricting Band (18"x1") 1 ea Gauze Sponge (4"x4") 2ea Safety
M68980801R060FRESH WHOLE BLOOD RECIPIENT SET Constricting Band (18"x1") 1 ea Gauze Sponge (4"x4") 2ea Safety

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