FDA.reportPublic FDA data

Fresh Whole Blood Donor Transfusion Set

Primary DI
M68980801D040
Brand
Fresh Whole Blood Donor Transfusion Set
Company
Safeguard US Operating, LLC
Model
4
Catalog number
80-801-D
Device description
"FRESH WHOLE BLOODDONOR SETConstricting Band (18”x1”) 1 ea Gloves (Pair) 1 eaGauze Sponge (4”x4”) 2 ea Alcohol Pads 2 eaBlood Tube- Lavender Top 4 ea Chlorhexidine Swab 1 eaBlood Tube- Red Top 2 ea 5.5” Kelly Clamp 1 eaBlood Collection Needle 21gx1.25"" 1 ea Nylon Cord (10”) 1 eaSurgical Tape 1 ea Permanent Marker 1 eaClear IV Dressing 1 ea ASBP 572 1 eaABO/Rh Screen (EldonCard) 1 ea Blood Bag Label 1 eaBlood Collection Bag 1 ea Instructions for Use 1 ea "
Published
2020-04-03
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Contact Domains#

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
M68980801D040PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Blood donor set, single-packAn assembly of sterile devices intended to be used to collect whole blood from a donor. It includes a container (a single flexible bag) with anticoagulation solution, tubing, and an attached needle for venipuncture. It may include integrated features such as an in-line leukocyte filter, pre-donation blood sampling device, and/or needle stick prevention device. After collection, the blood is tested, stored, and infused from the container when needed. This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Store at 20 to 25 degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
855-428-6074fulfillment@combatmedicalsystems.com

Regulatory Flags#

DUNS number
118492643
Device count
1
Premarket exempt
true
Kit
true
Lot or batch
true
Expiration date on label
true

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