Device
he Fresh Whole Blood Recipient Set contains everything needed to properly document recipient information, screen for ABO/Rh compatibility and transfuse fresh whole blood in a compa...
Manufacturer
Safeguard US Operating, LLC
Safeguard US Operating, LLC
Model: 12
Catalog: 80-801-R
DI: M68980801R120
Status: New
MRI: Labeling does not contain MRI Safety Information
Single-use: Yes
Rx: Yes
OTC: No
First Published: 2026-05-04
Current Version: 2026-05-12
Description
he Fresh Whole Blood Recipient Set contains everything needed to properly document recipient information, screen for ABO/Rh compatibility and transfuse 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.
Sterilization
Device Sterile:
No
Sterilization Prior To Use:
No
Regulatory & Distribution
Record Status:
Published
Version Number:
1
Record Key:
c154bbaf-78ea-4b8b-bcef-515fbbf3e848
Distribution Status:
In Commercial Distribution
DUNS Number:
118492643
Device Count:
1
DM Exempt:
No
Premarket Exempt:
Yes
HCT/P:
No
Kit:
Yes
Combination Product:
No
Lot/Batch Tracked:
Yes
Serial Number Tracked:
No
Manufacturing Date Tracked:
No
Expiration Date Tracked:
Yes
Donation ID Number Tracked:
No
Labeled Contains NRL:
No
Labeled No NRL:
No
Identifiers
Device ID:
M68980801R120
Type:
Primary
Issuing Agency:
HIBCC
GMDN
Code: 38569
Name: Blood transfusion set, non-exchange
Definition:
An intravascular administration set intended to be used to administer blood from a container to a patient's vascular system through a needle or catheter inserted into a vein. The device typically includes a needle or catheter, tubing, a flow regulator, a drip chamber, an infusion line filter, a stopcock, connectors between parts of the set, a side tube with a cap to serve as an injection site, and a hollow spike to penetrate and connect the tubing to an intravenous (IV) bag or other infusion fluid container. This is a single-use device.
FDA Product Codes
BRZ
Set, Blood Transfusion