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Air/Water Valve

FDA UDI

Class II (US FDA UDI)

by GA Health Company Limited

Identity

Trade Name
Air/Water Valve FDA UDI
Generic Name
Endoscope air/water valve, single-use FDA UDI
Model / Reference
EN10230 FDA UDI

Identifiers

Primary DI / UDI-DI
04897106951161 FDA UDI
FDA Product Code
OCX FDA UDI
GMDN Term
Endoscope air/water valve, single-use FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
876.1500 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Endoscope air/water valve, single-use

This endoscope air/water valve enables the operator to control inflow of medical gases for insufflation, and/or water for irrigation while preventing backflow. It is a single-use device that comes with its own expiration date, serial number, and lot/batch number. This device is not labeled as No Radiation Line (NRL) compliant, but does contain MRI safety information. Endoscope air/water valve is intended to be fitted to an endoscope air/water channel to facilitate safe medical procedures.

Similar devices

Also classified as Endoscope air/water valve, single-use.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
GA Health Company Limited

Sources (1)

  • FDA UDI 6dd14623-92c1-4676-a67b-599126484330 32 fields · synced Jun 24, 2026