FDA.reportPublic FDA data

CleanGuard

Primary DI
10653405986485
Brand
CleanGuard
Company
Conmed Corporation
Model
200310
Catalog number
200310
Device description
CleanGuard Disposable Endoscope Valves Set, Contains Air/Water Valve, Suction Valve, Biopsy Valve and Auxiliary Water Connector
Published
2020-04-15
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
OCXendoscopic irrigation/suction system

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OCXEndoscopic Irrigation/Suction SystemGastroenterology, Urology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K182998000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K182998000Andorate Auxiliary Water ConnectorSmartdata Suzhou Co., Ltd.2019-04-17OCX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
30653405986489PackageGS1200In Commercial Distribution
10653405986485PrimaryGS10
00653405986488Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
3065340598648930653405986489
1065340598648510653405986485
00653405986488006534059864886534059864880653405986488

GMDN Terms#

Term, Definition table
TermDefinition
Endoscope channel support kitA collection of sterile devices intended to be fitted to multiple endoscope working channels/ports to enable an endoscope operator control the function of the working channels/ports and prevent retrograde flow of fluids, gases, and other materials. It typically includes an endoscopic suction valve, an endoscopic air/water valve, and an endoscopic biopsy valve. This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00KEEP AWAY FROM SUNLIGHT

Contacts#

Phone, Email table
PhoneEmail
+1(800)237-0169CUSTOMER_SERVICE@CONMED.COM

Regulatory Flags#

DUNS number
071595540
Device count
200
Lot or batch
true
Expiration date on label
true
No natural rubber latex
true

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10845854032619CROSSFTTFT-45MTFT-45M2021-01-19
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10845854032657CROSSFTTFT-65MTFT-65M2021-01-19
10653405004646ELECTROLASE HYFRECATOR7-100-8BX7-100-8BX2016-09-24
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