Who else makes this device?

Name: Neonatal flow sensor insert
Brand: Neonatal flow sensor insert

Anesthesiology › TherapeuticVentilator, Continuous, Facility Use

Neonatal Flow Sensor Insert

Catalogue number 8410179, listed by Drägerwerk AG & Co. KGaA, Germany, 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

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 Neonatal flow sensor insert
Listed by	Drägerwerk AG & Co. KGaA, Germany
FDA product code	CBK
Device type	Ventilator, Continuous, Facility Use
Device class	Class 2
Regulation	21 CFR 868.5895
510(k)	K974176
Record published	2022-04-08
Record revised	2023-03-27 (version 3)

Specifications

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

Catalogue Numbers

Catalogue numbers for Neonatal flow sensor insert
Catalogue number	Size	Status
8410179		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

Recalls Naming This Product

1 recall names this product by its own identifier, the 510(k) it is cleared under.

Recalls naming the identifiers of Neonatal flow sensor insert
Recalled by	Identified by	Initiated	FDA class	Root cause	Reason	Quantity	Closed
Draeger, Inc.	510(k) number	2005-12-28	Not classified	Other	Failure to generate an alarm when an unintended disconnection occurrs	2261 units	2007-08-07

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.