Air/Water Bottle Tubing with CO2 Extend (for US Market)

FDA UDI

Class II (US FDA UDI)

by GA Health Company Limited

Identity

Trade Name: Air/Water Bottle Tubing with CO2 Extend (for US Market) FDA UDI
Generic Name: Endoscopic insufflation tubing set, single-use FDA UDI
Model / Reference: EN10922B FDA UDI

Identifiers

Primary DI / UDI-DI: 04897106954148 FDA UDI
FDA Product Code: OCX FDA UDI
GMDN Term: Endoscopic insufflation tubing set, 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

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

FDA UDI

Category: Endoscopic insufflation tubing set, single-use

Air/Water Bottle Tubing with CO2 Extend (for US Market) by GA Health Company Limited — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

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Manufacturer

Manufacturer: GA Health Company Limited

Sources (1)

FDA UDI e7c1f701-982b-43f3-9939-d5b7467e2d60 32 fields · synced Jun 1, 2026