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CAFREvent ALS+ CPAP

FDA UDI

Class II (US FDA UDI)

by O-Two Medical Technologies Inc

Identity

Trade Name
CAFREvent ALS+ CPAP FDA UDI
Generic Name
Pulmonary resuscitator, pneumatic, reusable FDA UDI
Device Name
CAREvent ALS+ CPAP is intended to provide artificial ventilation for patients during respiratory and cardiac arrest. The single control for the simultaneous adjustment of ventilation frequency and tidal volume has 12 settings for a range of patients from 20 kg body weight to large adults. A separate Manual/Automatic control allows the operator to turn off the automatic cycling and ventilate the patient manually. Patients are protected from over inflation and potential barotraumas by an audible Pressure Relief System. CAREvent ALS+ CPAP also includes an airway Pressure Gauge and pneumatic alarm for Low Pressure Input Pressure. It also allows the breathing patient to “Demand Breathe” on 100% oxygen at their own rate and volume. In addition, CAREvent ALS+ CPAP has an adjustable CPAP/PEEP mode, eliminating the need for an external PEEP valve or CPAP device. FDA UDI
Model / Reference
01CV4000-CPAP FDA UDI
Description
CAREvent ALS+ CPAP is intended to provide artificial ventilation for patients during respiratory and cardiac arrest. The single control for the simultaneous adjustment of ventilation frequency and tidal volume has 12 settings for a range of patients from 20 kg body weight to large adults. A separate Manual/Automatic control allows the operator to turn off the automatic cycling and ventilate the patient manually. Patients are protected from over inflation and potential barotraumas by an audible Pressure Relief System. CAREvent ALS+ CPAP also includes an airway Pressure Gauge and pneumatic alarm for Low Pressure Input Pressure. It also allows the breathing patient to “Demand Breathe” on 100% oxygen at their own rate and volume. In addition, CAREvent ALS+ CPAP has an adjustable CPAP/PEEP mode, eliminating the need for an external PEEP valve or CPAP device. FDA UDI

Identifiers

Catalog Number
01CV4000-CPAP FDA UDI
Primary DI / UDI-DI
07540195025325 FDA UDI
510(k) Number
K991195 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

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

No

FDA UDI

Lot / Batch Number

No

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI

Dimensions & Sizes

Size
Weight — 1.5 Kilogram FDA UDI
Height — 2.95 Inch FDA UDI
Width — 5.5 Inch FDA UDI
Length — 8.1 Inch FDA UDI

Category: Pulmonary resuscitator, pneumatic, reusable

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

Similar devices

Also classified as Pulmonary resuscitator, pneumatic, reusable.

Cleared under the same submission

K991195 also covers:

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 48cafaa6-1640-4901-858a-ee80b1fc92bd 38 fields · synced May 30, 2026