What is FDA product code PPA?

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 › TherapeuticBladder Irrigation Kit

Regard™

Name: Regard™
Brand: Regard™

3 catalogue numbers from UR0854, listed by Resource Optimization & Innovation, L.L.C., under Bladder Irrigation Kit. 2 manufacturers in China are registered for this product code.

Registry build 21.09.26

2manufacturers in China registered for this device type

3catalogue numbers in this listing

Who Else Makes It

Concentrated in Zhejiang (1), Guangdong (1).

Chinese manufacturers registered for FDA product code PPA
Manufacturer	City	Province	Registered as	Device types
GRI Medical & Electronic Technology Co., Ltd.	Jiaxing	Zhejiang	Contract manufacturer	71
Shenzhen Create Technology Co., Ltd.	Shenzhen	Guangdong	Manufacturer	9

Record

Regulatory record for Regard™
Listed by	Resource Optimization & Innovation, L.L.C.
FDA product code	PPA
Device type	Bladder Irrigation Kit
Device class	Class 2
Regulation	21 CFR 876.5130
Premarket notification	Exempt
Record published	2017-02-16
Record revised	2020-08-27 (version 4)

Specifications

Specifications
MRI safety	MR Safe
Supplied sterile	Yes
Single use	Yes
Prescription	Prescription only
Supplied as a kit	Yes
Latex	Contains natural rubber latex
Label carries	lot or batch number, expiry date
Packaging	Pack of 10, pack of 16
Distribution end date	2020-08-26

Catalogue Numbers

Catalogue numbers for Regard™
Catalogue number	Size	Status
UR0854		Withdrawn
UR0857		Withdrawn
UR0858		Withdrawn

Same Product Code

Other products under the same FDA product code
Product	Sold by	Catalogue numbers
Cardinal Health	Cardinal Health 200, LLC	3
Regard™	ROi CPS LLC	3
Medical Action Industries	Medical Action Industries, Inc.	3

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.