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

Defendo

Name: Defendo
Brand: Defendo

The single-use DEFENDO Olympus EUS Air Water Suction , Biopsy valve - 3-piece kit is used to control the air/water function of an endoscope during a Radial EUS GI procedure.

Registry build 21.09.26

2manufacturers in China registered for this device type

2catalogue 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 Defendo
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	2024-07-15

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, manufacturing date
Storage	Handling environment temperature 15 to 25 °C
Packaging	Case of 25

Catalogue Numbers

Catalogue numbers for Defendo
Catalogue number	Size	Status
00711901		In distribution
00711904		In distribution

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.