Who else makes this device?

Name: Ventilator 3 Section Arm with Ex
Brand: Ventilator 3 Section Arm with Ex

Anesthesiology › TherapeuticVentilator, Continuous, Facility Use

Ventilator 3 Section Arm With Ex

Catalogue number MEB-0094, listed by Flight Medical Innovations Ltd., Israel, under Ventilator, Continuous, Facility Use. 8 manufacturers in China are registered for this product code.

Registry build 21.09.26

8manufacturers in China registered for this device type

1catalogue number

5510(k) clearances naming this product code

1recall

Who Else Makes It

Concentrated in Guangdong (4), Jiangsu (2), Fujian (1). 6 of them are registered as contract manufacturers, able to build to a buyer’s own specification.

Chinese manufacturers registered for FDA product code CBK
Manufacturer	City	Province	Registered as	Device types
GaleMed (Xiamen) Co., Ltd.	Xiamen	Fujian	Contract manufacturer	33
Vincent Medical (Dong Guan) Manufacturing Co., Ltd.	Dong Guan	Guangdong	Contract manufacturer	29
Sanmina	Kunshan	Jiangsu	Contract manufacturer	15
Mehow Innovative (Huizhou) Ltd.	Huizhou	Guangdong	Contract manufacturer	11
Respironics Medical Products (Shenzhen) Co., Ltd.	Shenzhen	Guangdong	Contract manufacturer	8
Beijing Aeonmed Co., Ltd.	Sanhe	Hebei	Contract manufacturer	7
Shenzhen Mindray BIO-Medical Electronics Co., Ltd.	Shenzhen	Guangdong	Specification developer	61
GE Medical Systems (China) Co., Ltd.	Wuxi	Jiangsu	Contract manufacturer	57

Record

Regulatory record for Ventilator 3 Section Arm with Ex
Listed by	Flight Medical Innovations Ltd., Israel
FDA product code	CBK
Device type	Ventilator, Continuous, Facility Use
Device class	Class 2
Regulation	21 CFR 868.5895
Establishment	Contract manufacturer, Specification developer, Complaint-file establishment, Manufacturer, Exporter
Record published	2022-09-02

Specifications

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

Catalogue Numbers

Catalogue numbers for Ventilator 3 Section Arm with Ex
Catalogue number	Size	Status
MEB-0094		In distribution

Same Product Code

Other products under the same FDA product code
Product	Sold by	Catalogue numbers
Puritan Bennett	Covidien LP	285
Newport	Newport Medical Instruments, Inc.	103
LTV	Vyaire Medical, Inc.	92
Ventilator, Continuous, Facility Use	Hans Rudolph, Inc.	66
Infant Flow SiPAP	Carefusion	62
Avea	Carefusion	57
Ventoux	Flight Medical Innovations Ltd.	48
Trilogy	Respironics Inc.	42
Avea™	Vyaire Medical, Inc.	39
Patient Circuits	Zoll Medical Corporation	38
Performatrak	Respironics Inc.	35
Bio-Med Devices, Inc.	BIO-MED Devices, Inc.	34

Showing 12 of 419. All products under Ventilator, Continuous, Facility Use

510(K) Clearances

FDA 510(k) clearances naming this product code
Clearance	Decision date
K223120	2024-12-02
K143035	2016-03-30
K130171	2014-04-08
K120726	2012-07-06
K111683	2011-10-31

Recalls

The FDA has not published a severity grade for these. Volume alone is not a quality signal: a manufacturer that ships more recalls more.

Recalls referencing this product code
Initiated	FDA class	Root cause	Reason	Quantity	Closed
2011-08-10	Not classified	Device Design	The recall was initiated because Flight Medical Innovations Ltd. has identified a problem may occur when contact between an exposed unused wire and the grounding wire occurs. If this contact occurs the ventilator may reset and switch off.	363 total units, all in the US	2012-05-21

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.