FDA.reportPublic FDA data

Fresh Whole Blood Donor Transfusion Set

Primary DI
M68980801D110
Brand
Fresh Whole Blood Donor Transfusion Set
Company
Safeguard US Operating, LLC
Model
11
Catalog number
80-801-D
Device description
FRESH WHOLE BLOODDONOR SETConstricting Band (18”x1”) 1 ea Alcohol Pads 2 eaGauze Sponge 2 ea Chlorhexidine Swab 1 eaBlood Tube- Lavender Top 4 ea Kelly Clamp 1 eaBlood Tube- Red Top 2 ea Nylon Cord (10”) 1 eaBlood Collection Needle 1 ea Beaded Cable Tie 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 eaGloves (Pair) 1 ea
Published
2022-08-09
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#

Product Codes#

Code, Name table
CodeName
PDQNeurosurgical Nerve Locator

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PDQNeurosurgical Nerve LocatorEar, Nose, Throat2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
M68980801D110PrimaryHIBCC0

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

Other Devices From This Company#

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M6898010020040INTRAVENOUS INFUSION STARTER SET Case of 200480-100-202026-05-04
M68980801D160Fresh Whole Blood Donor Transfusion Set1680-801-D2026-05-04
M68980801R120Fresh Whole Blood Recipient Set1280-801-R2026-05-04
M6898250403050MEDIC ENHANCEMENT SET0582-504-032026-06-03
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M6898143003020Maritime Boat Box - Advanced0281-430-032026-05-28
M6898444601190Mojo Multi Mission - Advanced1984-446-012026-05-27
M689HHCTUINK01050Chest Tube Insertion Kit05HHCTUINK012026-05-27
M689HHCTUINK0105050Chest Tube Insertion Kit Cast of 505HHCTUINK01-052026-05-27
M689801101005080-110-10 Saline Lock Kit Case of 100580-110-102025-04-16
M68980110140SALINE LOCK KIT1480-1102025-01-11
M6898143003010Maritime Boat Box - Advanced0181-430-032025-07-11
M689HHCTUINK01040Chest Tube Insertion Kit04HHCTUINK012025-12-19

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
M68980801D160Fresh Whole Blood Donor Transfusion SetSafeguard US Operating, LLCPDQ2026-05-04
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00190376517506SafeOp 3ALPHATEC SPINE, INC.PDQ2024-11-12
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