What is FDA product code PNG?

For drainage of refractory ascites with long-term occurrence from the peritoneal cavity.

Gastroenterology & Urology › TherapeuticPeritoneal, Drainage Catheter For Refractory Ascites, Long-Term Indwelling

Asept

Name: Asept
Brand: Asept

Asept Peritoneal Drainage System

Registry build 21.09.26

2manufacturers in China registered for this device type

1catalogue number

Who Else Makes It

All of them in Guangdong. 2 of them are registered as contract manufacturers, able to build to a buyer’s own specification.

Chinese manufacturers registered for FDA product code PNG
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

Record

Regulatory record for Asept
Listed by	B. Braun Interventional Systems, Inc., United States
FDA product code	PNG
Device type	Peritoneal, Drainage Catheter For Refractory Ascites, Long-Term Indwelling
Device class	Class 2
Regulation	21 CFR 876.5630
510(k)	K093796
Record published	2015-07-26
Record revised	2024-04-16 (version 10)

Specifications

Specifications
MRI safety	Labeling does not contain MRI Safety Information
Supplied sterile	Yes
Single use	Yes
Prescription	Prescription only
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

Catalogue Numbers

Catalogue numbers for Asept
Catalogue number	Size	Status
622284		In distribution

Same Product Code

Other products under the same FDA product code
Product	Sold by	Catalogue numbers
Aspira®	Merit Medical Systems, Inc.	14
PeritX	Carefusion 2200, Inc.	6
PleurX	Carefusion 2200, Inc.	5
PeritX	Bard Peripheral Vascular, Inc.	3
Peritoneal, Drainage Catheter For Refractory Ascites, Long-Term Indwelling	Carefusion 2200, Inc.	2
Asept Peritoneal Drainage System	PFM Medical, Inc	1
Asept	PFM Medical, Inc	1

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.