Transfer Pack

Basic Information

• Brand Name: Transfer Pack
• Primary DI: 10811137010629
• Version / Model: 4R2004
• Catalog Number: 4R2004
• Company Name: FENWAL, INC.
• Labeler DUNS: 794519020
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 6
• Record Status: Published
• Publish Date: 2016-09-12
• Public Version: 4
• Public Version Date: 2023-04-21
• Public Version Status: Update
• Public Device Record Key: 4b452a8b-9ab8-4ead-b1dc-ba82ae4aa9f3
• Distribution End Date: 2019-03-18

Device Description

Quadruple Transfer Pack Container 150 mL with Coupler. 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
KSR	Container, Empty, For Collection & Processing Of Blood & Blood Components	Hematology	864.9100	2

GMDN Terms

Code	Name	Definition	Implantable	Status
44904	Blood/tissue storage/culture container	A receptacle intended for the storage and/or culture of tissue, cells, blood or blood components (e.g., peripheral blood stem cells) typically for subsequent therapeutic applications. It has a variety of shapes and sizes, may reduce the risk of contamination, may be used during freezing, and may be gas permeable. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	20811137010626	GS1	Box	8	Not in Commercial Distribution	2019-03-18
Primary	10811137010629	GS1
Secondary	0FE04R2004	ICCBBA
Unit of Use	00811137010622	GS1

Customer Contacts

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