AccessGUDID - DEVICE: Fresh Whole Blood Donor Transfusion Set (M68980801D150)

GUDID

Device Identifier (DI) Information

Brand Name: Fresh Whole Blood Donor Transfusion Set
Version or Model: 15
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 80-801-D
Company Name: Safeguard US Operating, LLC

Primary DI Number: M68980801D150
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 118492643 *Terms of Use

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.

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?
44033	Blood donor set, single-pack	An 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.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
PDQ	Neurosurgical Nerve Locator

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
Special Storage Condition, Specify: Store at 20 to 25 degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: c0bf3e25-fea5-4408-ab96-015cdc019d91
Public Version Date: March 12, 2025
Public Version Number: 1
DI Record Publish Date: March 04, 2025