CARevent CPAP

FDA UDI

Class II (US FDA UDI)

by O-Two Medical Technologies Inc

Identity

Trade Name: CARevent CPAP FDA UDI
Generic Name: In-line CPAP set, nebulizing FDA UDI
Device Name: The handheld CAREvent® CPAP provides CPAP delivery in a simple, compact device that can fit easily into existing oxygen kit. The ease-of-use design concept and unique single-use patient circuit with facemask, head harness and airway pressure gauge make application and operation of the O-Two CAREvent CPAP extremely simple for the rescuer and more comfortable and less distressing for the patient. FDA UDI
Model / Reference: 01CV0200-1 FDA UDI
Description: The handheld CAREvent® CPAP provides CPAP delivery in a simple, compact device that can fit easily into existing oxygen kit. The ease-of-use design concept and unique single-use patient circuit with facemask, head harness and airway pressure gauge make application and operation of the O-Two CAREvent CPAP extremely simple for the rescuer and more comfortable and less distressing for the patient. FDA UDI

Identifiers

Catalog Number: 01CV0200 FDA UDI
Primary DI / UDI-DI: 07540195036017 FDA UDI
510(k) Number: K093862 FDA UDI
FDA Product Code: BTL FDA UDI
BYE FDA UDI
GMDN Term: In-line CPAP set, nebulizing FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 868.5925 FDA UDI
868.5965 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

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Lot / Batch Number

FDA UDI

Serial Number

Yes

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Expiration Date

FDA UDI

Manufacturing Date

Yes

FDA UDI

Dimensions & Sizes

Size: Weight — 0.45 Kilogram FDA UDI
Height — 2.9 Inch FDA UDI
Width — 2.5 Inch FDA UDI
Length — 5.5 Inch FDA UDI

Category: In-line CPAP set, nebulizing

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

Similar devices

Also classified as In-line CPAP set, nebulizing.

VYGON — Vygon Corp. · Class II
Rescuer II Compact CPAP with Nebulizer Kit — B.L.S. Systems Limited · Class II
Curaplex — BOUND TREE MEDICAL, LLC · Class II
MACS — AIRON CORPORATION · Class II
Rescuer II Compact CPAP System with Small Deluxe CPAP Mask and Nebulizer Kit — B.L.S. Systems Limited · Class II
Curaplex — BOUND TREE MEDICAL, LLC · Class II
Curaplex — BOUND TREE MEDICAL, LLC · Class II
MACS — AIRON CORPORATION · Class II

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: O-Two Medical Technologies Inc

Sources (1)

FDA UDI e66dfc02-4d97-4811-b8bd-7b7e62154e20 38 fields · synced May 30, 2026