Fenwal Plasma Extractor

Basic Information

• Brand Name: Fenwal Plasma Extractor
• Primary DI: 04086000903226
• Version / Model: 4R4414
• Catalog Number: 4R4414
• Company Name: Fresenius Kabi AG
• Labeler DUNS: 315654579
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2020-06-24
• Public Version: 1
• Public Version Date: 2020-07-02
• Public Version Status: New
• Public Device Record Key: 9a1fbf1d-21bf-4549-94ec-09642f33a6cb

Device Description

Fenwal Plasma Extractor

Device Characteristics

• Single Use: No
• 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: No
• Has Manufacturing Date: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
KSS	Supplies, Blood-Bank	Hematology	864.9050	1

GMDN Terms

Code	Name	Definition	Implantable	Status
62648	Blood component separator, manual	A manually-operated device designed for the separation of previously centrifuged blood into components [e.g., red blood cells (RBCs), plasma, platelets] for further processing or storage. It is a compact mechanical unit (non-powered) that uses pressure plates to facilitate the transfer of each component from the donor bag into a respective collection bag. It is typically used in a blood bank or transfusion centre, and is not donor or patient connected.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	04086000903226	GS1
Package	14086000903223	GS1	Carton	1	In Commercial Distribution

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: Per product labeling: When not in use, store in closed position.