AccessGUDID - DEVICE: Fresh Whole Blood Recipient Set (M68980801R080)

GUDID

Device Identifier (DI) Information

Brand Name: Fresh Whole Blood Recipient Set
Version or Model: 08
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 80-801-R
Company Name: Safeguard US Operating, LLC

Primary DI Number: M68980801R080
Issuing Agency: HIBCC
Commercial Distribution End Date: June 05, 2023
Device Count: 1
Labeler D-U-N-S® Number*: 118492643 *Terms of Use

Device Description: FRESH WHOLE BLOOD RECIPIENT SET Constricting Band (18"x1") 1 ea Gauze Sponge 2 ea Safety IV Catheter 16gx1.25" 1 ea Safety IV Catheter 18gx1.25" 1 ea IV Set "Y" - Type with Filter 1 ea Surgical Tape 1 ea Clear IV Dressing 1 ea ABO/Rh Screen (EldonCard) 1 ea Gloves 1 pr Alcohol Pads 2 ea Chlorhexidine Swab 1 ea Permanent Marker 1 ea SF 518 1 ea Instructions for Use 1 ea

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: b4846301-3cc0-4c6a-b172-68d070971b43
Public Version Date: December 17, 2024
Public Version Number: 2
DI Record Publish Date: September 30, 2022