What is FDA product code PPB?

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 › TherapeuticFoley Catheter Kit (Excludes Hiv Testing)

Clarity RMS Sensor Tray

Name: Clarity RMS Sensor Tray
Brand: Clarity RMS Sensor Tray

Catalogue number KIT00013, listed by RenalSense Ltd., under Foley Catheter Kit (Excludes Hiv Testing). 2 manufacturers in China are registered for this product code.

Registry build 21.09.26

2manufacturers in China registered for this device type

1catalogue number

Who Else Makes It

Concentrated in Jiangsu (1), Zhejiang (1). One is registered as a contract manufacturer, able to build to a specification.

Chinese manufacturers registered for FDA product code PPB
Manufacturer	City	Province	Registered as	Device types
Amsino Medical (Kunshan) Co., Ltd.	Kunshan	Jiangsu	Contract manufacturer	53
Joykey Industrial (Pinghu) Limited	Pinghu	Zhejiang	Contract manufacturer	43

Record

Regulatory record for Clarity RMS Sensor Tray
Listed by	RenalSense Ltd.
FDA product code	PPB
Device type	Foley Catheter Kit (Excludes Hiv Testing)
Device class	Class 2
Regulation	21 CFR 876.5130
Premarket notification	Exempt
Record published	2019-10-02

Specifications

Specifications
MRI safety	MR Conditional
Supplied sterile	Yes
Single use	Yes
Prescription	Prescription only
Latex	Labelled latex-free
Label carries	lot or batch number, expiry date
Packaging	Master box of 10

Catalogue Numbers

Catalogue numbers for Clarity RMS Sensor Tray
Catalogue number	Size	Status
KIT00013		In distribution

Same Product Code

Other products under the same FDA product code
Product	Sold by	Catalogue numbers
Medline Industries, Inc.	Medline Industries, Inc.	343
Medline	Medline Industries, Inc.	6
Dover	Cardinal Health 200, LLC	6
Centurion Medical Products Corp	Medline Industries, Inc.	1
Cardinal Health	Cardinal Health 200, LLC	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.