Infant Flow SiPAP

Infant Flow Sipap Transducer Interface General Assembly

Registry build 21.09.26
8manufacturers in China registered for this device type
62catalogue numbers in this listing

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 Infant Flow SiPAP
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 2015-09-16
Record revised 2024-06-17 (version 4)

Specifications

Specifications
MRI safety MR Unsafe
Single use Yes
Prescription Prescription only
Latex Labelled latex-free
Label carries lot or batch number, serial number
Distribution end date 2022-03-31

Catalogue Numbers

Catalogue numbers for Infant Flow SiPAP
Catalogue number Size Status
777000L Withdrawn
777028 Withdrawn
7772021 Withdrawn
12204-101 Withdrawn
777040S Withdrawn
777002XS Withdrawn
777085-102 Withdrawn
777000XL Withdrawn
11513-103 Withdrawn
775728 Withdrawn
777002L Withdrawn
12204-102 Withdrawn
777002S Withdrawn
777084-101 Withdrawn
777040XL Withdrawn
11513-102 Withdrawn
773389-104 Withdrawn
777084-107 Withdrawn
27416-001 Withdrawn
777024 Withdrawn
777010 Withdrawn
675-CFG-005 Withdrawn
777002M Withdrawn
7772020LP Withdrawn
777012 Withdrawn
777084-112 Withdrawn
773389-105 Withdrawn
777084-103 Withdrawn
7772011 Withdrawn
777000M Withdrawn
777018 Withdrawn
777026 Withdrawn
777022 Withdrawn
777086-103 Withdrawn
D1420/100 Withdrawn
27415-001 Withdrawn
777014 Withdrawn
7772010 Withdrawn
777084-106 Withdrawn
777016 Withdrawn
777084-108 Withdrawn
777086-102 Withdrawn
777000XS Withdrawn
777086-104 Withdrawn
777040L Withdrawn
777020 Withdrawn
777002XL Withdrawn
777084-110 Withdrawn
11513-101 Withdrawn
777084-111 Withdrawn
777040SM Withdrawn
777215 Withdrawn
777084-105 Withdrawn
777084-104 Withdrawn
777040M Withdrawn
777086-101 Withdrawn
677-002 Withdrawn
467349 Withdrawn
777040XS Withdrawn
777000S Withdrawn
777084-102 Withdrawn
7772000LP 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
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
Vent Zoll Medical Corporation 32

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