FDA.report

A/W Channel Cleaning Adapter + 3-piece Valve Kit

Primary DI
14897106953407
Brand
A/W Channel Cleaning Adapter + 3-piece Valve Kit
Company
GA Health Company Limited
Model
GAR3804
Published
2021-03-12
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

Product Codes

CodeName
OCXEndoscopic Irrigation/Suction System

Product Code Classifications

CodeDeviceSpecialtyClass
OCXEndoscopic Irrigation/Suction SystemGastroenterology, Urology2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
14897106953407PackageGS110In Commercial Distribution
24897106953404PackageGS140In Commercial Distribution
04897106953400PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
1489710695340714897106953407
2489710695340424897106953404
04897106953400048971069534004897106953400

GMDN Terms

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.

Sterilization Methods

Method

Regulatory Flags

DUNS number
686908512
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
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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