LTV 1150 Ventilator

Assy, LTV1150, W/ Access, English

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 LTV 1150 Ventilator
Listed by Carefusion, United States
FDA product code CBK
Device type Ventilator, Continuous, Facility Use
Device class Class 2
Regulation 21 CFR 868.5895
Establishment Specification developer, Manufacturer
Record published 2015-09-29
Record revised 2024-07-30 (version 6)

Specifications

Specifications
MRI safety MR Unsafe
Prescription Prescription only
Latex Contains natural rubber latex
Label carries serial number
Distribution end date 2022-03-31

Catalogue Numbers

Catalogue numbers for LTV 1150 Ventilator
Catalogue number Size Status
18984-001 Withdrawn

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

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.

Where China Actually Supplies

Every device page names the company that lists it and the factories registered to make the same thing. These are the sections with the most of them.

5,100manufacturers registered in China
2,581device types they are registered for
340,248device records, each naming its maker
31provinces with a registered manufacturer