FDA.reportPublic FDA data

Fresh Whole Blood Donor Transfusion Set

Primary DI
M68980801D160
Brand
Fresh Whole Blood Donor Transfusion Set
Company
Safeguard US Operating, LLC
Model
16
Catalog number
80-801-D
Device description
The Fresh Whole Blood Donor Set contains everything needed to properly document donor information, screen for ABO/Rh, collect samples for retrospective testing and perform the collection of one unit of fresh whole blood in a compact sealed package.The transfusion of fresh whole blood is the best option for management of casualties with hemorrhagic shock. Blood transfusions have been used successfully in military conflicts and other austere conditions to resuscitate trauma patients suffering from shock due to hemorrhage.
Published
2026-05-04
Public version status
New
Distribution status
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
M68980801D160PrimaryHIBCC0

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

Contacts#

Phone, Email table
PhoneEmail
855-428-6074sales@safeguardmedical.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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M689HHCTUINK01040Chest Tube Insertion Kit04HHCTUINK012025-12-19
M689HHCTUINK0105040Chest Tube Insertion Kit Cast of 504HHCTUINK01-052025-12-19
M6898444601180Mojo Multi Mission - Advanced1884-446-012025-04-10
M68988143020Micro Trauma Kit - Intermediate0288-1432019-10-29
M6898130301130MARCH IFAK RESUPPLY1381-303-012026-05-05
M68980100150INTRAVENOUS INFUSION STARTER SET 1580-1002026-05-04
M6898010020040INTRAVENOUS INFUSION STARTER SET Case of 200480-100-202026-05-04
M68980801R120Fresh Whole Blood Recipient Set1280-801-R2026-05-04
M6898130301120MARCH IFAK RESUPPLY1281-303-012025-08-18
M68980801D150Fresh Whole Blood Donor Transfusion Set1580-801-D2025-03-04
M68980801R110Fresh Whole Blood Recipient Set1180-801-R2025-03-04
M68980100140INTRAVENOUS INFUSION STARTER SET 1480-1002024-12-27
M6898010020030INTRAVENOUS INFUSION STARTER SET Case of 200380-100-202024-12-27
M68980801R100Fresh Whole Blood Recipient Set1080-801-R2024-12-16
M68980801050Fresh Whole Blood Transfusion Set580-8012022-08-09
M6898141003030Maritime First Aid Resupply - Advanced0381-410-032026-04-07
M689WJBBC4010Bleeding Control Kit Plus 6/cs 01WJBBC42026-04-02

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