What is FDA product code PQE?

This product code has been established in accordance with the May 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm080217.pdf. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.

Gastroenterology & Urology › TherapeuticOstomy Care Kit

Brava

Name: Brava
Brand: Brava

Catalogue number 12014, listed by Coloplast A/S, Denmark, under Ostomy Care Kit. 3 manufacturers in China are registered for this product code.

Registry build 21.09.26

3manufacturers in China registered for this device type

1catalogue number

Who Else Makes It

Concentrated in Zhejiang (2), Jiangsu (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 PQE
Manufacturer	City	Province	Registered as	Device types
Zhende Medical Co., Ltd.	Shaoxing	Zhejiang	Contract manufacturer	14
Shaoxing Haoshide Medical Products Co., Ltd.	Shaoxing	Zhejiang	Contract manufacturer	7
Suzhou Kangyouwei Medical Technology Co., Ltd.	Suzhou	Jiangsu	Manufacturer	3

Record

Regulatory record for Brava
Listed by	Coloplast A/S, Denmark
FDA product code	PQE
Device type	Ostomy Care Kit
Device class	Class 1
Regulation	21 CFR 876.5900
Establishment	Specification developer, Manufacturer
Premarket notification	Exempt
Record published	2022-12-05

Specifications

Specifications
MRI safety	Labeling does not contain MRI Safety Information
Single use	Yes
Over the counter	Yes
Label carries	lot or batch number, expiry date
Packaging	Retail box of 30, shipper box of 40

Catalogue Numbers

Catalogue numbers for Brava
Catalogue number	Size	Status
12014		In distribution

Same Product Code

Other products under the same FDA product code
Product	Sold by	Catalogue numbers
New Image	Hollister Incorporated	44
Natura	Convatec, Purchasing Department	12
CeraPlus	Hollister Incorporated	11
Bynex	Shaoxing Haoshide Medical Products Co., Ltd.	10
Hollister	Hollister Incorporated	6
Premier	Hollister Incorporated	5
ZD	Zhende Medical Co., Ltd.	2
Bynex	Zhende Medical Co., Ltd.	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.