Who else makes this device?

Name: Blood and Infusion Warmer
Brand: Blood and Infusion Warmer

General Hospital › TherapeuticWarmer, Thermal, Infusion Fluid

Blood and Infusion Warmer

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…

Registry build 21.09.26

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.

1manufacturer

1catalogue number

1510(k) clearance

Who Else Makes It

Registered in Guangdong. One is registered as a contract manufacturer, able to build to a specification.

Chinese manufacturers registered for FDA product code LGZ
Manufacturer	City	Province	Registered as	Device types
Dongguan BAO Kang Dian ZI KE JI Limited	Dongguan	Guangdong	Contract manufacturer	24

Record

Regulatory record for Blood and Infusion Warmer
Listed by	Biegler Gmbh, Austria
FDA product code	LGZ
Device type	Warmer, Thermal, Infusion Fluid
Device class	Class 2
Regulation	21 CFR 880.5725
Establishment	Contract manufacturer, Manufacturer
510(k)	K121198
Record published	2020-06-19
Record revised	2022-03-22 (version 2)

Specifications

Specifications
MRI safety	Labeling does not contain MRI Safety Information
Label carries	manufacturing date, serial number

Catalogue Numbers

Catalogue numbers for Blood and Infusion Warmer
Catalogue number	Size	Status
BW 685		In distribution

Same Product Code

Other products under the same FDA product code
Product	Sold by	Catalogue numbers
Pedigo Products, Inc.	Pedigo Products, Inc.	207
Amsco	Steris Corporation	38
Level 1	ICU Medical, Inc	26
Skytron warming cabinet	Skytron, LLC	24
ThermaCor 1200 Infusion System	Smisson-Cartledge Biomedical LLC	11
Astoflo® Plus ECO	Stihler Electronic Gmbh	10
enFlow	Carefusion	8
Fluido® AirGuard System	The Surgical Company International B.V.	7
Smithworks Medical, Inc.	Smithworks, Inc.	5
Warming Cabinet Single Compartment Counter-Top Model (Glass Door)	Imperial Surgical Ltd.	4
Hang&Go PAC	Rand SPA	4
enFlow™	Airlife, Inc.	4

Showing 12 of 159. All products under Warmer, Thermal, Infusion Fluid

510(K) Clearances

FDA 510(k) clearances naming this product code
Clearance	Decision date
K121198	2012-07-12

Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.