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Fenwal Hand Sealer

FDA UDI

Class I (US FDA UDI)

by Fresenius Kabi

Identity

Trade Name
Fenwal Hand Sealer FDA UDI
Generic Name
Laboratory tubing welder FDA UDI
Device Name
The Hand Sealer is used to provide a hermetic closure on Blood-Pack Unit tubings when used with the Fenwal Hand Sealer Clips, code 4R4418. FDA UDI
Model / Reference
4R4454W FDA UDI
Description
The Hand Sealer is used to provide a hermetic closure on Blood-Pack Unit tubings when used with the Fenwal Hand Sealer Clips, code 4R4418. FDA UDI

Identifiers

Catalog Number
4R4454W FDA UDI
Primary DI / UDI-DI
00810020441062 FDA UDI
FDA Product Code
LXG FDA UDI
GMDN Term
Laboratory tubing welder FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
862.2050 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

No

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

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Laboratory tubing welder

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

Similar devices

Also classified as Laboratory tubing welder.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Fresenius Kabi

Sources (1)

  • FDA UDI e4748e37-3d05-4ca9-8152-b7d0dc49d14e 34 fields · synced May 30, 2026