FDA.reportPublic FDA data

DEFENDO SINGLE USE VALVE KIT

Primary DI
00677964103926
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
2019-06-04
Public version status
Update
Distribution status
Not 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
ODCEndoscope Channel Accessory

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NWUEndoscope Introducer KitGastroenterology, Urology2
ODCEndoscope Channel AccessoryGastroenterology, Urology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
40677964010604PackageGS150In Commercial Distribution
00677964103926PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
4067796401060440677964010604
00677964103926006779641039266779641039260677964103926

GMDN Terms#

Term, Definition table
TermDefinition
Device lumen cleaning attachment, single-useA device intended to be fitted to a luminal device (e.g., catheter, endoscope air/water channel, vitrectomy handpiece) to assist with the cleaning/flushing of the lumen of the device during a medical/surgical procedure and/or for maintenance pre/post procedure. It is typically in the form of a small, cylindrical rod(s) with a button/switch which controls the supply of air and/or water; it may include tubing and/or be used in conjunction with a syringe, device washer/decontaminator, and/or water tap. This is a single-use device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)444-4729custserv@MEDIVATORS.com
+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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Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
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00677964052491CER-2 OptimaCER-2 OptimaCER2OPTIMA2016-09-20
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