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O-Two

FDA UDI

Class I (US FDA UDI)

by O-Two Medical Technologies Inc

Identity

Trade Name
O-Two FDA UDI
Generic Name
Medical gas flowmeter, dial-type FDA UDI
Device Name
FLOW CONTROL 0-25 LPM O2 DISS. The O-Two Adjustable Oxygen Therapy Flow Controller is a calibrated, 12-position, fixed orifice, non-gravity sensitive flow controller. FDA UDI
Model / Reference
01FCO125D FDA UDI
Description
FLOW CONTROL 0-25 LPM O2 DISS. The O-Two Adjustable Oxygen Therapy Flow Controller is a calibrated, 12-position, fixed orifice, non-gravity sensitive flow controller. FDA UDI

Identifiers

Primary DI / UDI-DI
07540195050075 FDA UDI
FDA Product Code
CCN FDA UDI
GMDN Term
Medical gas flowmeter, dial-type FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
868.2300 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

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

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Medical gas flowmeter, dial-type

O-Two by O-Two Medical Technologies Inc — 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

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Manufacturer

Manufacturer
O-Two Medical Technologies Inc

Sources (1)

  • FDA UDI 23deb297-c733-4bb7-8eaa-6c4fe24b2d52 34 fields · synced May 30, 2026