Insufflation tube

FDA UDI

Class II (US FDA UDI)

by Guangdong Optomedic Technologies, Inc.

Identity

Trade Name: Insufflation tube FDA UDI
Generic Name: Endoscopic insufflation tubing set, reusable FDA UDI
Model / Reference: OPTO-T1000 FDA UDI

Identifiers

Primary DI / UDI-DI: 06973031299573 FDA UDI
510(k) Number: K231342 FDA UDI
FDA Product Code: HIF FDA UDI
GMDN Term: Endoscopic insufflation tubing set, reusable FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 884.1730 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

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

FDA UDI

Manufacturing Date

Yes

FDA UDI

Sterilization Method

Moist Heat or Steam Sterilization FDA UDI

Category: Endoscopic insufflation tubing set, reusable

Insufflation tube by Guangdong Optomedic Technologies, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Cleared under the same submission

K231342 also covers:

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: Guangdong Optomedic Technologies, Inc.

Sources (1)

FDA UDI cd641e20-7526-478d-a42f-f16fbaf26c90 33 fields · synced May 30, 2026