FDA.reportPublic FDA data

DEFENDO SINGLE USE VALVE KIT

Primary DI
00677964092992
Brand
DEFENDO SINGLE USE VALVE KIT
Company
MEDIVATORS INC.
Model
100322
Catalog number
100322
Device description
DEFENDO Single Use Valve Kit-Air Water, Suction, Biopsy Valves, Cleaning Adapter with Endogator Connector for Olympus GI Endoscopes
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
FDFColonoscope And Accessories, Flexible/Rigid
MNLAccessories, Cleaning Brushes, For Endoscope
NWUEndoscope introducer kit

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FDFColonoscope And Accessories, Flexible/RigidGastroenterology, Urology2
MNLAccessories, Cleaning Brushes, For EndoscopeGastroenterology, Urology1
NWUEndoscope Introducer KitGastroenterology, Urology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K090851000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K090851000DEFENDO (TM) BIOPSY VALVE FOR OLYMPUS(R) AND FUJINON(R) ENDOSCOPES, MODEL 100301, DEFENDO(TM) BIOPSY VALVE FOR PENTAX(R)Byrne Medical, Inc.2009-07-02ODC

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
40677964009998PackageGS150In Commercial Distribution
00677964092992PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
4067796400999840677964009998
00677964092992006779640929926779640929920677964092992

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

Other Devices From This Company#

Primary DI, Brand, Model table
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00677964153617Endo Carry-on Procedure Kit401122140112212026-05-26
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00677964153631Endo Carry-on Procedure Kit401123040112302026-05-26

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Primary DI, Brand, Company table
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