Asept

Asept Pleural Drainage System

Registry build 21.09.26
3manufacturers in China registered for this device type
5catalogue numbers in this listing

Who Else Makes It

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

Chinese manufacturers registered for FDA product code DWM
Manufacturer City Province Registered as Device types
Turnxon Precision Co., Ltd. Dongguan Guangdong Contract manufacturer 17
Alleva Medical (D.G.) Ltd Dongguan Guangdong Contract manufacturer 13
Ningbo Chibanda IMP &EXP Co., Ltd. Ningbo Zhejiang Manufacturer 59

Record

Regulatory record for Asept
Listed by B. Braun Interventional Systems, Inc., United States
FDA product code DWM
Device type Apparatus, Suction, Patient Care
Device class Class 2
Regulation 21 CFR 870.5050
Record published 2015-07-26
Record revised 2023-09-07 (version 9)

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Supplied sterile Yes
Single use Yes
Prescription Prescription only
Supplied as a kit Yes
Latex Labelled latex-free
Label carries lot or batch number, expiry date
Storage Special storage condition: KEEP DRY; Special storage condition: Keep away from sunlight; Special storage condition: Store at room temp
Sizes Total volume 600 to 1000 ml

Catalogue Numbers

Catalogue numbers for Asept
Catalogue number Size Per pack Status
622289 In distribution
622279 Total Volume 1000.0 ml 10 In distribution
622287 Total Volume 600.0 ml 10 In distribution
622288 5 In distribution
622286 10 In distribution

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
Aspira® Merit Medical Systems, Inc. 20
PleurX Carefusion 2200, Inc. 14
Apparatus, Suction, Patient Care Carefusion 2200, Inc. 3
Rocket Rocket Medical PLC 3
Aspira Drainage Tray Bard Access Systems, Inc. 3
Asept Pleural Drainage System PFM Medical, Inc 2
Passio Redressing Kit Bearpac Medical, LLC 2
Passio Handheld Control Unit Bearpac Medical, LLC 1
Passio Disposable Collection System Bearpac Medical, LLC 1
Passio Adapter Kit Bearpac Medical, LLC 1
Aspira Drainage Kit Bard Access Systems, Inc. 1
Passio Valve Cap Kit Bearpac Medical, LLC 1

Showing 12 of 17. All products under Apparatus, Suction, Patient Care

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