CAREvent MRI

FDA UDI

Class II (US FDA UDI)

by O-Two Medical Technologies Inc

Identity

Trade Name: CAREvent MRI FDA UDI
Generic Name: Portable pneumatic ventilator FDA UDI
Device Name: CAREvent MRI is pneumatically powered, time/volume cycled, intermittent positive pressure patient ventilators specifically designed for use by trained personnel in the pre-hospital, hospital, interhospital and air ambulance environments. It has independent controls for minute volume and frequency that provide a comprehensive range of 12 ventilation frequencies and 12 minute-volume settings. This provides a possible 144 combinations of delivered tidal volume and respiratory rate. The various modes of operation of the ventilators support the resuscitation and transportation of a wide range of patients (from infants to adults). The CAREvent MRI contains no ferrous metals and is suitable for use in a three-Tesla MRI environment. FDA UDI
Model / Reference: 01CV7000 FDA UDI
Description: CAREvent MRI is pneumatically powered, time/volume cycled, intermittent positive pressure patient ventilators specifically designed for use by trained personnel in the pre-hospital, hospital, interhospital and air ambulance environments. It has independent controls for minute volume and frequency that provide a comprehensive range of 12 ventilation frequencies and 12 minute-volume settings. This provides a possible 144 combinations of delivered tidal volume and respiratory rate. The various modes of operation of the ventilators support the resuscitation and transportation of a wide range of patients (from infants to adults). The CAREvent MRI contains no ferrous metals and is suitable for use in a three-Tesla MRI environment. FDA UDI

Identifiers

Catalog Number: 01CV7000 FDA UDI
Primary DI / UDI-DI: 07540195030183 FDA UDI
510(k) Number: K051469 FDA UDI
FDA Product Code: BTL FDA UDI
GMDN Term: Portable pneumatic ventilator 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

MRI Safety

MR Conditional FDA UDI

Dimensions & Sizes

Size: Weight — 6.25 Pound FDA UDI
Height — 4.3 Inch FDA UDI
Width — 6.5 Inch FDA UDI
Length — 9.25 Inch FDA UDI

Category: Portable pneumatic ventilator

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

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pNeuton — AIRON CORPORATION · Class II
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Percussionaire — Percussionaire Corporation · Class II
PAHI VersalVent — Pan-America Hyperbarics, Inc. · 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 16d0f66f-a9c6-4241-a426-2081a0c55d20 38 fields · synced Jun 8, 2026