FDA.report

DEFENDO

Primary DI
50724995228908
Brand
DEFENDO
Company
MEDIVATORS INC.
Model
Defendo Fujifilm 700 Series
Catalog number
100325
Device description
Defendo for Fuji 700, 5-piece Single Use Valve Kit with Air Water, Suction, Biopsy Valve, Connector, Cleaning Adapter
Published
2024-01-18
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Related Records

Contact Domains

Product Codes

CodeName
FEQPUMP, AIR, NON-MANUAL, FOR ENDOSCOPE

Product Code Classifications

CodeDeviceSpecialtyClass
FEQPump, Air, Non-Manual, For EndoscopeGastroenterology, Urology2

Premarket Submissions

SubmissionSupplement
K232329000

Premarket Details

SubmissionSupplementDeviceApplicantDecision dateProduct code
K232329000Defendo Fujifilm 700 Single Use Biopsy Valve; Defendo Fujifilm 700 Single Use Air/Water Valve; Defendo Fujifilm 700 Single Use Suction Valve; ENDOGATOR Fujifilm 700 Single Use Connector; Defendo Fujifilm 700 Single Use Cleaning AdapterMedivators (A Subsidiary of Steris Corporation)2023-12-21ODC

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
50724995228908PackageGS150In Commercial Distribution
00724995228903PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
5072499522890850724995228908
00724995228903007249952289037249952289030724995228903

GMDN Terms

TermDefinition
Endoscope flushing adaptor, single-useA small attachment designed to be fitted to an endoscope port for flushing of the endoscope’s lumen(s) during post-procedural washing, disinfection and/or sterilization. It is in the form of a plug that may include a button/switch for control of fluid (e.g., sterilant, disinfectant) and/or air through the lumen; it does not include tubing (i.e., not a tubing set). This is a single-use device.

Sterilization Methods

Method

Contacts

PhoneEmail
+1(800)444-4729custserv@MEDIVATORS.com

Regulatory Flags

DUNS number
068199363
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
true
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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