What is FDA product code NWU?

This product code has been established in accordance with the May 20, 1997, Guidance entitled, Convenience Kits Interim Regulatory Guidance, found at www.fda.gov/cdrh/ode/convkit.html. This kit, as described in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market.

Gastroenterology & Urology › DiagnosticEndoscope Introducer Kit

Endoscope Introducer Kit

Name: Endoscope Introducer Kit
Brand: Endoscope Introducer Kit

The Irrigation Kit CO2 Short includes 1 AquaShield System CO2 and 1 Torrent Irrigation Tubing.

Registry build 21.09.26

2manufacturers in China registered for this device type

7catalogue numbers in this listing

Who Else Makes It

All of them in Jiangsu. One is registered as a contract manufacturer, able to build to a specification.

Chinese manufacturers registered for FDA product code NWU
Manufacturer	City	Province	Registered as	Device types
Yangzhou Fartley Medical Instrument Technology Co., Ltd.	Yangzhou	Jiangsu	Contract manufacturer	24
Changzhou Endoclean Medical Device Co., Ltd.	Changzhou	Jiangsu	Repacker / relabeller	13

Record

Regulatory record for Endoscope Introducer Kit
Listed by	Us Endoscopy, United States
FDA product code	NWU
Device type	Endoscope Introducer Kit
Device class	Class 2
Regulation	21 CFR 876.1500
Premarket notification	Exempt
Record published	2017-04-07
Record revised	2022-06-10 (version 7)

Specifications

Specifications
MRI safety	Labeling does not contain MRI Safety Information
Supplied sterile	Yes
Prescription	Prescription only
Supplied as a kit	Yes
Latex	Labelled latex-free
Label carries	lot or batch number, expiry date, manufacturing date
Storage	Storage environment temperature 15 to 25 °C
Packaging	Box of 20, case of 20
Distribution end date	2023-11-13

Catalogue Numbers

Catalogue numbers for Endoscope Introducer Kit
Catalogue number	Size	Status
00711559		Withdrawn
00711556		Withdrawn
00711558		Withdrawn
00711555		Withdrawn
00711556		Withdrawn
00711557		Withdrawn
00711554		Withdrawn

Same Product Code

Other products under the same FDA product code
Product	Sold by	Catalogue numbers
Cardinal Health	Cardinal Health 200, LLC	10,257
Endo Carry-on Procedure Kit	Medivators Inc	1,777
Custom Procedure KIT	Medivators Inc	573
VIA	Us Endoscopy	519
ACS	American Contract Systems, Inc.	416
Medline Industries, Inc.	Medline Industries, Inc.	337
Zutron Medical	Zutron Medical, L.L.C.	80
Medical Action Industries	Medical Action Industries, Inc.	54
Essential Kit	Medivators Inc	44
Preclean Kit	Medivators Inc	31
VIA procedure kit – custom	Us Endoscopy	29
Endo Carry-on Custom Procedure Kit	Medivators Inc	23

Showing 12 of 23. All products under Endoscope Introducer Kit

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.