What is FDA product code PRR?

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 › TherapeuticFeeding Tube Kit

Centurion

Name: Centurion
Brand: Centurion

Catalogue number IFK840, listed by Centurion Medical Products Corporation, United States, under Feeding Tube Kit. 1 manufacturer in China is registered for this product code.

Registry build 21.09.26

1manufacturer

1catalogue number

Who Else Makes It

Registered in Jiangsu.

Chinese manufacturers registered for FDA product code PRR
Manufacturer	City	Province	Registered as	Device types
Suzhou Texnet	Suzhou	Jiangsu	Contract manufacturer	47

Record

Regulatory record for Centurion
Listed by	Centurion Medical Products Corporation, United States
FDA product code	PRR
Device type	Feeding Tube Kit
Device class	Class 2
Regulation	21 CFR 876.5980
Premarket notification	Exempt
Record published	2016-09-13
Record revised	2018-06-05 (version 3)

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
Packaging	Case of 48
UDI direct marking	Exempt

Catalogue Numbers

Catalogue numbers for Centurion
Catalogue number	Size	Status
IFK840		In distribution

Same Product Code

Other products under the same FDA product code
Product	Sold by	Catalogue numbers
Entuit	Cook Incorporated	8
Cardinal Health	Cardinal Health 200, LLC	2
Medline	Medline Industries, Inc.	2

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.