Low Titer Type O Donor Collection Set

Basic Information

• Brand Name: Low Titer Type O Donor Collection Set
• Primary DI: M68980875D020
• Version / Model: 02
• Catalog Number: 80-875-D
• 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: 2018-09-18
• Public Version: 5
• Public Version Date: 2022-04-12
• Public Version Status: Update
• Public Device Record Key: 01bbb1ff-f92d-496c-8dc1-5d539c38c9b8
• Distribution End Date: 2021-05-31

Device Description

LOW TITER TYPE O DONOR COLLECTION SET Constricting Band (18"x1") 1 ea Safety IV Catheter 16gx1.25" 2 ea Transparent Film Dressing 2 ea Chlorhexidine Swap 4 ea Blood Collection Bag 1 ea Beaded Cable Tie 1ea Needle-Free Valve with Luer Lock 2 ea DD Form 572 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	M68980875D020	HIBCC

Customer Contacts

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