Fresh Whole Blood Donor Transfusion Set 80-801-D

GUDID M68980801D110

FRESH WHOLE BLOOD DONOR SET Constricting Band (18”x1”) 1 ea Alcohol Pads 2 ea Gauze Sponge 2 ea Chlorhexidine Swab 1 ea Blood Tube- Lavender Top 4 ea Kelly Clamp 1 ea Blood Tube- Red Top 2 ea Nylon Cord (10”) 1 ea Blood Collection Needle 1 ea Beaded Cable Tie 1 ea Surgical Tape 1 ea Permanent Marker 1 ea Clear IV Dressing 1 ea ASBP 572 1 ea ABO/Rh Screen (EldonCard) 1 ea Blood Bag Label 1 ea Blood Collection Bag 1 ea Instructions for Use 1 ea Gloves (Pair) 1 ea

Safeguard US Operating, LLC

Blood donor set, single-pack
Primary Device IDM68980801D110
NIH Device Record Key6ef66480-03b7-4192-b2e0-5d52401c9743
Commercial Distribution StatusIn Commercial Distribution
Brand NameFresh Whole Blood Donor Transfusion Set
Version Model Number11
Catalog Number80-801-D
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
HIBCCM68980801D110 [Primary]

FDA Product Code

PDQNeurosurgical Nerve Locator

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-08-17
Device Publish Date2022-08-09

On-Brand Devices [Fresh Whole Blood Donor Transfusion Set]

M68980801D0Designed for missions in the most remote and austere environments, the Fresh Whole Blood Donor S
M68980801D110FRESH WHOLE BLOOD DONOR SET Constricting Band (18”x1”) 1 ea

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