FDA.reportPublic FDA data

DEFENDO Air/Water and Suction Valves

Primary DI
00677964055935
Brand
DEFENDO Air/Water and Suction Valves
Company
MEDIVATORS INC.
Model
100317
Catalog number
100317
Device description
Defendo Pentax Single Use Air Water and Suction Valve 2-piece kit
Published
2016-09-21
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
ODCEndoscope channel accessory

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FDFColonoscope And Accessories, Flexible/RigidGastroenterology, Urology2
ODCEndoscope Channel AccessoryGastroenterology, Urology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K102409000
K102581000
K232004000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K102409000DEFENDO DISPOSABLE AIR/WATER VALVE MODEL 100304Byrne Medical, Inc.2010-11-04ODC
K102581000DEFENDO DISPOSABLE SUCTION VALVE MODEL 100305Byrne Medical, Inc.2010-11-08ODC
K232004000Defendo Pentax Single Use Biopsy Valve, Defendo Pentax Single Use Air/Water Valve, Defendo Pentax Single Use Suction Valve, Endogator Pentax Single Use ConnectorMedivators (A Subsidiary of Steris Corporation)2024-03-06ODC

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10677964055932PackageGS150In Commercial Distribution
20677964055939PackageGS1100In Commercial Distribution
00677964055935PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1067796405593210677964055932
2067796405593920677964055939
00677964055935006779640559356779640559350677964055935

GMDN Terms#

Term, Definition table
TermDefinition
Endoscopic suction valve, single-use, sterileA sterile device intended to be fitted to an endoscope suction channel to enable the operator to control suction whist preventing inflow of air. It is in the form of an attachable valve that controls (opens/closes) the suction channel. 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
Kit
true
Lot or batch
true
Expiration date on label
true

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