O-Two

FDA UDI

Class I (US FDA UDI)

by O-Two Medical Technologies Inc

Identity

Trade Name: O-Two FDA UDI
Generic Name: Ventilator breathing circuit, single-use FDA UDI
Device Name: The O-Two single-use ventilation circuit is designed to be used with ventilators, demand valve or gas mixers to deliver oxygen or nitrous oxide and oxygen mixture gas to patients. It consists of one corrugated breathing hose, an inspiratory one-way valve, and a PEEP port. The 01CV8019 with anti-entrainment flapper and facemask/mouth piece is specifically designed for use with O-Two Equinox Relieve and Equinox Advantage nitrous oxide and oxygen gas mixing and delivery units. FDA UDI
Model / Reference: 01CV8019 FDA UDI
Description: The O-Two single-use ventilation circuit is designed to be used with ventilators, demand valve or gas mixers to deliver oxygen or nitrous oxide and oxygen mixture gas to patients. It consists of one corrugated breathing hose, an inspiratory one-way valve, and a PEEP port. The 01CV8019 with anti-entrainment flapper and facemask/mouth piece is specifically designed for use with O-Two Equinox Relieve and Equinox Advantage nitrous oxide and oxygen gas mixing and delivery units. FDA UDI

Identifiers

Catalog Number: 01CV8019-CS FDA UDI
Primary DI / UDI-DI: 07540195005211 FDA UDI
FDA Product Code: CAI FDA UDI
GMDN Term: Ventilator breathing circuit, single-use FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 868.5240 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

Yes

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

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

FDA UDI

Dimensions & Sizes

Size: Weight — 80 Gram FDA UDI
Length — 40 Inch FDA UDI

Category: Ventilator breathing circuit, single-use

O-Two by O-Two Medical Technologies Inc — Class I — 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 I	Pending data

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Manufacturer

Manufacturer: O-Two Medical Technologies Inc

Sources (1)

FDA UDI 36f5098e-6cb1-464c-98aa-3866f03226e2 37 fields · synced Jun 8, 2026