AccessGUDID - DEVICE: Fresh Whole Blood Recipient Set (M68980801R020)

GUDID

Device Identifier (DI) Information

Brand Name: Fresh Whole Blood Recipient Set
Version or Model: 2
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 80-801-R
Company Name: Safeguard US Operating, LLC

Primary DI Number: M68980801R020
Issuing Agency: HIBCC
Commercial Distribution End Date: May 04, 2018
Device Count: 1
Labeler D-U-N-S® Number*: 118492643 *Terms of Use

Device Description: Designed for missions in the most remote and austere environments, the Fresh Whole Blood Transfusion Set contains essential items to collect and transfuse fresh whole blood in a compact sealed package. The set includes a donor module, blood collection bag and recipient module; that allow for donor collection and the ability to perform a transfusion procedure to the recipient. Product Description In remote areas and combat environments where definitive care may be too far away or inaccessible, transfusion of fresh whole blood may be the best option for management of hemorrhagic shock in casualties. Blood transfusions have been used successfully in military conflicts and other austere conditions to resuscitate trauma patients suffering from hemorrhagic shock. Developed with extensive research and feedback from the Armed Services Blood Program Office, the Fresh Whole Blood Transfusion Set contains everything needed to test for ABO/Rh compatibility and perform a fresh whole blood transfusion in a compact sealed package. NOTE: Only personnel trained in blood collection, transfusion, and management of transfusion reactions should use this set.

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	Yes
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
38569	Blood transfusion set, non-exchange	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.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
BRZ	Set, Blood Transfusion

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: Yes CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 15bc21b4-9487-44ba-a892-983b8455b741
Public Version Date: April 12, 2022
Public Version Number: 5
DI Record Publish Date: August 04, 2017