Extension Set

FDA UDI

Class II (US FDA UDI)

by Biegler GmbH

Identity

Trade Name: Extension Set FDA UDI
Generic Name: Conduction blood/fluid warmer set FDA UDI
Device Name: Disposable product for single use only. Sterile and pyrogen-free flow tube. For use with Biegler blood and infusion warmer. Luer-Lock with injection port. FDA UDI
Model / Reference: 46000 FDA UDI
Description: Disposable product for single use only. Sterile and pyrogen-free flow tube. For use with Biegler blood and infusion warmer. Luer-Lock with injection port. FDA UDI

Identifiers

Primary DI / UDI-DI: 09008247000259 FDA UDI
510(k) Number: K121198 FDA UDI
FDA Product Code: LGZ FDA UDI
GMDN Term: Conduction blood/fluid warmer set FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 880.5725 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

FDA UDI

Category: Conduction blood/fluid warmer set

Extension Set by Biegler GmbH — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Conduction blood/fluid warmer set.

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Ranger™ — 3M COMPANY · Class II
Life Warmer Quantum Thermal Transfusion Set for Blood and Blood Products (TTS-B) — NORTH AMERICAN RESCUE, LLC. · Class II
Ranger™ — 3M COMPANY · Class II
Ranger™ — 3M COMPANY · Class II
Ranger™ Novaplus™ — 3M COMPANY · Class II

Cleared under the same submission

K121198 also covers:

Blood and Infusion Warmer — Biegler GmbH
Extension Set — Biegler GmbH
Extension Set — Biegler GmbH

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

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Manufacturer

Manufacturer: Biegler GmbH

Sources (1)

FDA UDI 936f5ac1-5bb2-47ce-9c25-8f15defba9e1 34 fields · synced May 30, 2026