CAREvent CA

FDA UDI

Class II (US FDA UDI)

by O-Two Medical Technologies Inc

Identity

Trade Name: CAREvent CA FDA UDI
Generic Name: Pulmonary resuscitator, pneumatic, reusable FDA UDI
Device Name: CAREvent CA hand held automatic resuscitator is pneumatically powered, time/volume cycled ventilatlatory resuscitator. It provides trained individuals with a safe and effective means of providing artificial ventilation during respiratory and cardiac arrest. The CAREvent CA delivers automatic ventilation with controlled flow rate, airway pressure, tidal volume and frequency. Patients are protected from over inflation and potential barotraumas by an audible Pressure Relief System. In addition, CAREvent ALS, CA, DRA and Genesis II allow the breathing patient to “Demand Breathe” on 100% oxygen at their own rate and volume. The CAREvent CA is designed for resuscitation in toxic environments. A constant bleed flow reduces the risk of a patient drawing toxic air into the mask should a leak occur. FDA UDI
Model / Reference: 01CV3000-CA FDA UDI
Description: CAREvent CA hand held automatic resuscitator is pneumatically powered, time/volume cycled ventilatlatory resuscitator. It provides trained individuals with a safe and effective means of providing artificial ventilation during respiratory and cardiac arrest. The CAREvent CA delivers automatic ventilation with controlled flow rate, airway pressure, tidal volume and frequency. Patients are protected from over inflation and potential barotraumas by an audible Pressure Relief System. In addition, CAREvent ALS, CA, DRA and Genesis II allow the breathing patient to “Demand Breathe” on 100% oxygen at their own rate and volume. The CAREvent CA is designed for resuscitation in toxic environments. A constant bleed flow reduces the risk of a patient drawing toxic air into the mask should a leak occur. FDA UDI

Identifiers

Catalog Number: 01CV3000-CA FDA UDI
Primary DI / UDI-DI: 07540195025202 FDA UDI
510(k) Number: K051889 FDA UDI
FDA Product Code: BTL FDA UDI
GMDN Term: Pulmonary resuscitator, pneumatic, reusable FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 868.5925 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

FDA UDI

Lot / Batch Number

FDA UDI

Serial Number

Yes

FDA UDI

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: Pulmonary resuscitator, pneumatic, reusable

CAREvent CA by O-Two Medical Technologies Inc — Class II — 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 II	Pending data

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Manufacturer

Manufacturer: O-Two Medical Technologies Inc

Sources (1)

FDA UDI 8880b856-0f2c-466c-a315-e696d5ec3cbd 38 fields · synced May 30, 2026