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
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
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
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
true
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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M68920510050Sentinel Chest Trauma Kit0520-5102022-08-18
M68920510030Sentinel Chest Trauma Kit0320-5102018-09-13
M6898332401060Mojo Combat Lifesaver Bag - Basic0683-324-012019-08-06
M68985205020Mojo Vehicle Rescue Bag - Advanced0285-2052026-07-22
M68985301040Mojo Vehicle Medical Bag - Basic0485-3012026-07-22
M68985303040Mojo Vehicle Medical Bag - Intermediate0485-3032026-07-22
M6898710003060Individual Trauma Kit - Advanced0687-100-032026-07-22
M6898730002040Medical Trauma Kit Shelter in Place (Intermediate)0487-300-022026-07-22
M6898730003050Medical Trauma Kit Shelter in Place (Advanced)0587-300-032026-07-22
M689HHCTUINK01030Chest Tube Insertion Kit03HHCTUINK012025-06-23
M689HHCTUINK0105030Chest Tube Insertion Kit Cast of 503HHCTUINK01-052025-06-23
M6898810502020Patrol Officer IFAK Intermediate0288-105-022018-09-20
M6898810503020Patrol Officer IFAK Advanced0288-105-032018-09-20
M6898810502030Patrol Officer IFAK Intermediate0388-105-022020-01-06
M6898810503030Patrol Officer IFAK Advanced0388-105-032020-01-06
M689PBEFAK010Point Blank Enterprises Employee FAK - Private Label01PBEFAK2026-07-09
M689SHSTARTPAXSM030SCHOOL TRAUMA ADVANCED RESPONSE KIT03SH-START-PAX-SM2026-06-22
M689SHSTARTSM030School Trauma Active Response Kit03SH-START-SM2026-06-22

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