NA

Basic Information

• Brand Name: NA
• Primary DI: 00811137010455
• Version / Model: 4C2160
• Catalog Number: 4C2160
• Company Name: FENWAL, INC.
• Labeler DUNS: 794519020
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-12
• Public Version: 5
• Public Version Date: 2020-11-19
• Public Version Status: Update
• Public Device Record Key: bf875486-2f3c-4db3-8c52-9014184fc340
• Distribution End Date: 2018-03-20

Device Description

Blood Component Recipient Set with Standard Blood Filter with Luer Adapter. Sterile Fluid Path

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• 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: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• 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
Package	10811137010452	GS1	Box	48	Not in Commercial Distribution	2018-03-20
Primary	00811137010455	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K073339	000