FDA.reportPublic FDA data

DEFENDO SINGLE USE VALVE KIT

Primary DI
00724995246839
Brand
DEFENDO SINGLE USE VALVE KIT
Company
MEDIVATORS INC.
Model
100323
Catalog number
100323
Device description
The Defendo Sigle Use Valve kit 4-piece kit includes Air Water, Suction and Biopsy Valves and a Cleaning Adapter.
Published
2026-04-06
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
NWUEndoscope introducer kit

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NWUEndoscope Introducer KitGastroenterology, Urology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10724995246836PackageGS150In Commercial Distribution
00677964103926PreviousGS10
00724995246839PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1072499524683610724995246836
00677964103926006779641039266779641039260677964103926
00724995246839007249952468397249952468390724995246839

GMDN Terms#

Term, Definition table
TermDefinition
Endoscope air/water valve, single-useA device intended to be fitted to an endoscope air/water channel to enable the operator to control inflow of medical gases [i.e., air, carbon dioxide (CO2)] for insufflation, and/or water for irrigation, whilst preventing backflow. It is in the form of an attachable inflow valve with closed and open settings. This is a single-use device.

Contacts#

Phone, Email table
PhoneEmail
+1(800)548-4873xx@xx.xx

Regulatory Flags#

DUNS number
068199363
Device count
1
Premarket exempt
true
Kit
true
Lot or batch
true
Expiration date on label
true

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