Puritan Bennett

D/Flex Inspiratory Filter Disposable 22mm ISO Conical Inlet / 22mm ISO Conical Outlet

Registry build 21.09.26
15manufacturers in China registered for this device type
6catalogue numbers in this listing

Who Else Makes It

Concentrated in Jiangsu (6), Guangdong (4), Zhejiang (3). 10 of them are registered as contract manufacturers, able to build to a buyer’s own specification.

Chinese manufacturers registered for FDA product code CAH
Manufacturer City Province Registered as Device types
Conod Medical Co., Limited Changshu Jiangsu Contract manufacturer 48
Flexicare Medical (Dongguan) Ltd. Dongguan Guangdong Contract manufacturer 48
GaleMed (Xiamen) Co., Ltd. Xiamen Fujian Contract manufacturer 33
Vincent Medical (Dong Guan) Manufacturing Co., Ltd. Dong Guan Guangdong Contract manufacturer 29
Amsino Medical (Shanghai) Co., Ltd. Shanghai Shanghai Contract manufacturer 22
Zhejiang Haisheng Medical Device Co., Ltd. Shaoxing Zhejiang Contract manufacturer 21
Sunmed AP, Ltd. Zhuhai Guangdong Contract manufacturer 18
Sunmed AP, Ltd., Warehouse NO. 2 Zhuhai Guangdong Contract manufacturer 16
Intersurgical Medical Apparatus (Changzhou) Co., Ltd. Changzhou Jiangsu Contract manufacturer 12
GVS Technology (Suzhou) Co., Ltd. Suzhou Jiangsu Contract manufacturer 5
Changshu Rozer Sterilization Technology Co., Ltd. Changshu Jiangsu Contract manufacturer 43
Rozer Sterilization Technology Shuyang Company Limited Shuyang Jiangsu Contract manufacturer 33

Showing 12 of 15. All 15 manufacturers in China registered for Filter, Bacterial, Breathing-Circuit

Record

Regulatory record for Puritan Bennett
Listed by Covidien LP, United States
FDA product code CAH
Device type Filter, Bacterial, Breathing-Circuit
Device class Class 2
Regulation 21 CFR 868.5260
Premarket notification Exempt
Record published 2016-09-24
Record revised 2025-06-24 (version 11)

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Single use Yes
Prescription Prescription only
Label carries lot or batch number, expiry date, manufacturing date
Storage Handling environment temperature up to 275 °F
Packaging Case of 10, case of 12, pack_or_inner_pack of 50, case of 3
Sizes Length 6 ft
Distribution end date 2022-03-30

Catalogue Numbers

Catalogue numbers for Puritan Bennett
Catalogue number Size Per pack Status
4-074602-00 In distribution
4-074603-00 12 In distribution
4-074601-00 In distribution
4-074600-00 In distribution
M-261000-04 Length 6 ft Withdrawn
4-074605-00 12 Withdrawn

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
Medline Industries, Inc. Medline Industries, Inc. 405
Pulmoguard S D I Diagnostics Inc 203
Cardinal Health Cardinal Health 200, LLC 131
DAR Covidien LP 110
Portex ICU Medical, Inc 108
Vital Signs™ SunMed Group Holdings, LLC 78
Pentair Pentair Filtration Solutions 68
Disposable Anesthesia Circuits Westmed, Inc. 68
AirLife™ AirLife Finland Oy 43
Ventlab Ventlab, LLC 40
VBMax A-M Systems 39
Vital Signs™ AirLife Finland Oy 38

Showing 12 of 545. All products under Filter, Bacterial, Breathing-Circuit

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