o_two CPAP

FDA UDI

Class II (US FDA UDI)

by O-Two Medical Technologies Inc

Identity

Trade Name: o_two CPAP FDA UDI
Generic Name: CPAP/BPAP face mask, single-use FDA UDI
Device Name: The O-Two single-use open CPAP delivery system provides 5-20 cmH2O CPAP pressure to patients. The adjustment of the CPAP level is achieved by adjusting the output flow from oxygen therapy regulator or wall outlet. The setting selections noted on the device provide an accurate constant airway pressure at each flow setting. FDA UDI
Model / Reference: 01CV0229 FDA UDI
Description: The O-Two single-use open CPAP delivery system provides 5-20 cmH2O CPAP pressure to patients. The adjustment of the CPAP level is achieved by adjusting the output flow from oxygen therapy regulator or wall outlet. The setting selections noted on the device provide an accurate constant airway pressure at each flow setting. FDA UDI

Identifiers

Catalog Number: 01CV0229-CS FDA UDI
Primary DI / UDI-DI: 07540195035140 FDA UDI
510(k) Number: K112546 FDA UDI
FDA Product Code: BYE FDA UDI
GMDN Term: CPAP/BPAP face mask, single-use FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 868.5965 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

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 — 0.1 Kilogram FDA UDI

Category: CPAP/BPAP face mask, single-use

o_two CPAP by O-Two Medical Technologies Inc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as CPAP/BPAP face mask, single-use.

BiTrac Select — Pulmodyne Inc. · Class II
Nebulizing Elbow — Respironics, Inc. · Class II
Fisher & Paykel Healthcare — FISHER & PAYKEL HEALTHCARE, INC. · Class II
AF541 — Respironics, Inc. · Class II
BiTrac SE Select — Pulmodyne Inc. · Class II
Veraseal 3 Full Face Vented Mask, Small — Sleepnet Corporation · Class II
Varifit NIV Non Vented Mask With Anti-Asphyxiation Valve, Small Adult — Sleepnet Corporation · Class II
AF531 — Respironics, Inc. · Class II

Cleared under the same submission

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

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

Manufacturer

Manufacturer: O-Two Medical Technologies Inc

Sources (1)

FDA UDI 211acad4-1c3d-4c0e-8d40-5b58d395fa21 38 fields · synced May 30, 2026