← Back to catalogue

Gentec®

FDA UDI

Class I (US FDA UDI)

by Gentec(shanghai)corporation

Identity

Trade Name
GENTEC® FDA UDI
Generic Name
Medical gas flowmeter, dial-type FDA UDI
Device Name
CFM series flowmeter is for medical gas supply system, providing measurement and control for gas supply. It is designed for flow control and monitor on patient's inhalation, and other medical devices' flow control and monitor as well. FDA UDI
Model / Reference
CFM-25L FDA UDI
Description
CFM series flowmeter is for medical gas supply system, providing measurement and control for gas supply. It is designed for flow control and monitor on patient's inhalation, and other medical devices' flow control and monitor as well. FDA UDI

Identifiers

Primary DI / UDI-DI
06970966662816 FDA UDI
FDA Product Code
BYX FDA UDI
GMDN Term
Medical gas flowmeter, dial-type FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
868.5860 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

No

FDA UDI

Over-the-Counter

Yes

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

No

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Medical gas flowmeter, dial-type

Gentec® by Gentec(shanghai)corporation — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Medical gas flowmeter, dial-type.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
Gentec(shanghai)corporation

Sources (1)

  • FDA UDI d0e81e04-3641-4855-b4e8-9f19e2b8d1e1 34 fields · synced May 30, 2026