Identity
- Trade Name
- Blood and Infusion Warmer FDA UDI
- Generic Name
- Conduction blood/fluid warmer FDA UDI
- Device Name
- The BIEGLER BW 685 / BW 685 S is a warmer for infusions or transfusions and operates on the basis of a continuous flow warmer, where the heat from the heat exchanger is transferred via the extension sets (consumables) to the liquid flowing within it. FDA UDI
- Model / Reference
- BW 685 FDA UDI
- Description
- The BIEGLER BW 685 / BW 685 S is a warmer for infusions or transfusions and operates on the basis of a continuous flow warmer, where the heat from the heat exchanger is transferred via the extension sets (consumables) to the liquid flowing within it. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 09008247000501 FDA UDI
- 510(k) Number
- K121198 FDA UDI
- FDA Product Code
- LGZ FDA UDI
- GMDN Term
- Conduction blood/fluid warmer 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
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
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Conduction blood/fluid warmer
Blood and Infusion Warmer by Biegler GmbH — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Conduction blood/fluid warmer.
- Ranger™ — 3M COMPANY · Class II
- ThermaCor 1200 Infusion System — Smisson-Cartledge Biomedical, LLC · Class II
- Curaplex — BOUND TREE MEDICAL, LLC · Class II
- ASTOLINE — Stihler Electronic GmbH · Class II
- ASTOTHERM® PLUS — Stihler Electronic GmbH · Class II
- EXPRESS FLUID WARMER — NxStage Medical, Inc. · Class II
- °M Warmer System - Charger — Mequ A/S · Class II
- ASTOFLO® PLUS ECO — Stihler Electronic GmbH · Class II
Cleared under the same submission
K121198 also covers:
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 a6c3749c-8004-431a-adb0-cd33b9f62d95 34 fields · synced May 31, 2026