Who else makes this device?

Name: QIF-01-12 extended kit
Brand: QIF-01-12 extended kit

General Hospital › TherapeuticWarmer, Thermal, Infusion Fluid

QIF-01-12 Extended Kit

QinFlow Warrior Extreme system kit - the QiF warmer is a portable, inline blood and fluid warmer system. The QiF Blood and Fluid Warmer is located between the fluid container (intravenous…

Registry build 21.09.26

QinFlow Warrior Extreme system kit – the QiF warmer is a portable, inline blood and fluid warmer system. The QiF Blood and Fluid Warmer is located between the fluid container (intravenous fluid, blood or blood product) and treated patient, outside of the patient’s body. The kit contains 2 batteries. The S/N of the kit is identical to the S/N of the Base Unit inside the kit.

1manufacturer

1catalogue number

5510(k) clearances naming this product code

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 QIF-01-12 extended kit
Listed by	Quality IN Flow Ltd., Israel
FDA product code	LGZ
Device type	Warmer, Thermal, Infusion Fluid
Device class	Class 2
Regulation	21 CFR 880.5725
Establishment	Manufacturer
Record published	2023-01-04

Specifications

Specifications
MRI safety	MR Unsafe
Prescription	Prescription only
Supplied as a kit	Yes
Label carries	manufacturing date, serial number

Catalogue Numbers

Catalogue numbers for QIF-01-12 extended kit
Catalogue number	Size	Status
QIF-01-12		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
K211800	2022-12-08
K180154	2018-04-27
K171215	2017-09-27
K163708	2017-04-20
K150404	2016-06-23

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.