NA

Basic Information

• Brand Name: NA
• Primary DI: 10811137010704
• Version / Model: 4C2243
• Catalog Number: 4C2243
• Company Name: FENWAL, INC.
• Labeler DUNS: 794519020
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 2
• Record Status: Published
• Publish Date: 2016-09-12
• Public Version: 3
• Public Version Date: 2019-11-08
• Public Version Status: Update
• Public Device Record Key: 312db0ab-9cd7-453a-83ee-763111e560be
• Distribution End Date: 2018-05-28

Device Description

Plasma Transfer Sets with Two Spikes. 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: Yes
• 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
KSB	Set, Transfer (Blood/Plasma)	Hematology	864.9875	2

GMDN Terms

Code	Name	Definition	Implantable	Status
44903	Blood transfer set	A collection of sterile, flexible, plastic tubing and associated items (e.g., couplers, adapters, clamps) used to transfer blood or blood components (e.g., peripheral stem cells, plasma) into containers or between containers for processing or storage (e.g., freezing). This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	20811137010701	GS1	Box	48	Not in Commercial Distribution	2018-05-28
Primary	10811137010704	GS1
Unit of Use	00811137010707	GS1

Customer Contacts

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