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

VIA Procedure Kit – Custom

Name: VIA procedure kit - custom
Brand: VIA procedure kit - custom

The VIA Procedure Kit - custom includes transport pad, gauze pads, suction tubing, basin, BioShield biopsy valve, biohazard sticker, lubricating jelly, DuoSwift combination brush, BioGuard…

Registry build 21.09.26

The VIA Procedure Kit – custom includes transport pad, gauze pads, suction tubing, basin, BioShield biopsy valve, biohazard sticker, lubricating jelly, DuoSwift combination brush, BioGuard air water and suction valves, and Torrent scope connector.

2manufacturers in China registered for this device type

29catalogue 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 VIA procedure kit – custom
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	2018-07-17
Record revised	2020-02-03 (version 4)

Specifications

Specifications
MRI safety	Labeling does not contain MRI Safety Information
Single use	Yes
Prescription	Prescription only
Supplied as a kit	Yes
Label carries	lot or batch number, expiry date
Packaging	Box of 20, box of 18, box of 12, case of 12, case of 20, case of 18
Distribution end date	2022-06-03

Catalogue Numbers

Catalogue numbers for VIA procedure kit – custom
Catalogue number	Size	Status
00717083		In distribution
00717095		In distribution
00717098		Withdrawn
00717104		Withdrawn
00717096		Withdrawn
00717084		Withdrawn
00717097		Withdrawn
00717105		Withdrawn
00717103		Withdrawn
00717091		Withdrawn
00717088		Withdrawn
00717094		Withdrawn
00717104		Withdrawn
00717088		Withdrawn
00717085		Withdrawn
00717092		Withdrawn
00717087		Withdrawn
00717083		Withdrawn
00717108		Withdrawn
00717102		Withdrawn
00717106		Withdrawn
00717093		Withdrawn
00717106		Withdrawn
00717101		Withdrawn
00717095		Withdrawn
00717086		Withdrawn
00717099		Withdrawn
00717089		Withdrawn
00717090		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
Endo Carry-on Custom Procedure Kit	Medivators Inc	23
Merit Medical®	Merit Medical Systems, Inc.	17

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.