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.

Medline · Feeding Tube Kit → Gastroenterology & Urology

Name: Medline
Brand: Medline

1manufacturer

2catalogue numbers in this listing

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 Medline
Listed by	Medline Industries, Inc., 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	2020-04-15
Record revised	2022-06-17 (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 20
UDI direct marking	Exempt

Catalogue Numbers

Catalogue numbers for Medline
Catalogue number	Size	Status
DYNDA2517A		In distribution
DYNDA2517		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
Centurion	Centurion Medical Products Corporation	1

Recalls Naming This Product

2 recalls name this product by its own identifiers, the UDI on its label.

Recalls naming the identifiers of Medline
Recalled by	Identified by	Initiated	FDA class	Root cause	Reason	Quantity
Medline Industries, LP – Northfield	UDI-DI	2026-03-19	Class II	Under Investigation by firm	During an internal review, Medline identified higher-than-expected endotoxin levels on a representative Medline neuro sponge product, indicating that in-market product may be out-of-specification for endotoxin.	263739 kits
Medline Industries, LP – Northfield	UDI-DI	2024-11-21	Class II	Nonconforming Material/Component	Custom convenience kits are being recall because the contain non-sterile Codman Surgical Patties & Surgical Strips, which have the potential for endotoxin contamination.	65310 units

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.

Medline