← Back to catalogue

Fenwal Plasma Extractor

FDA UDI

Class I (US FDA UDI)

by Fresenius Kabi

Identity

Trade Name
Fenwal Plasma Extractor FDA UDI
Generic Name
Blood component separator, manual FDA UDI
Device Name
Fenwal Plasma Extractor FDA UDI
Model / Reference
4R4414 FDA UDI
Description
Fenwal Plasma Extractor FDA UDI

Identifiers

Catalog Number
4R4414 FDA UDI
Primary DI / UDI-DI
04086000903226 FDA UDI
FDA Product Code
KSS FDA UDI
GMDN Term
Blood component separator, manual FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
864.9050 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

No

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Blood component separator, manual

Fenwal Plasma Extractor by Fresenius Kabi — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Blood component separator, manual.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
Fresenius Kabi

Sources (1)

  • FDA UDI 9a1fbf1d-21bf-4549-94ec-09642f33a6cb 35 fields · synced Jun 8, 2026