Fresh Whole Blood Recipient Set

Basic Information

• Brand Name: Fresh Whole Blood Recipient Set
• Primary DI: M68980801R060
• Version / Model: 06
• Catalog Number: 80-801-R
• Company Name: Safeguard US Operating, LLC
• Labeler DUNS: 118492643
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2021-10-02
• Public Version: 3
• Public Version Date: 2022-09-28
• Public Version Status: Update
• Public Device Record Key: e578aaa7-592c-4776-be1c-0ca3d6f0823c
• Distribution End Date: 2022-04-28

Device Description

FRESH WHOLE BLOOD RECIPIENT SET Constricting Band (18"x1") 1 ea Gauze Sponge (4"x4") 2ea 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 (pair) 1 ea Alcohol Pads 2 ea Chlorhexidine Swap 1 ea Permanent Marker 1 ea SF 518 1 ea Instructions for Use 1 ea

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: Yes
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: Yes
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
BRZ	Set, Blood Transfusion	General Hospital	880.5440	2

GMDN Terms

Code	Name	Definition	Implantable	Status
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.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	M68980801R060	HIBCC

Customer Contacts

• Phone: [phone]
• Email: [email protected]