CAREvent PAR

FDA UDI

Class II (US FDA UDI)

by O-Two Medical Technologies Inc

Identity

Trade Name: CAREvent PAR FDA UDI
Generic Name: Pulmonary resuscitator, pneumatic, reusable FDA UDI
Device Name: CAREvent PAR assists the rescuer in providing efficient and effective CPR by providing with audible and visual prompts for chest compression, ventilation timing and automatic ventilation. The visual prompts aid the rescuer in their CPR efforts by providing illuminated pictograms of the CPR process, timed with the audible voice prompts. These voice and visual prompts help to significantly reduce interruptions in chest compression. The audible and visual warnings of mask leakage or airway obstruction assist the rescuer in ensuring that adequate tidal volumes are delivered. FDA UDI
Model / Reference: 01CV0100 FDA UDI
Description: CAREvent PAR assists the rescuer in providing efficient and effective CPR by providing with audible and visual prompts for chest compression, ventilation timing and automatic ventilation. The visual prompts aid the rescuer in their CPR efforts by providing illuminated pictograms of the CPR process, timed with the audible voice prompts. These voice and visual prompts help to significantly reduce interruptions in chest compression. The audible and visual warnings of mask leakage or airway obstruction assist the rescuer in ensuring that adequate tidal volumes are delivered. FDA UDI

Identifiers

Catalog Number: 01CV0100 FDA UDI
Primary DI / UDI-DI: 07540195025349 FDA UDI
510(k) Number: K081330 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 — 1.2 Kilogram FDA UDI
Height — 3.1 Inch FDA UDI
Width — 9.6 Inch FDA UDI
Length — 9.8 Inch FDA UDI

Category: Pulmonary resuscitator, pneumatic, reusable

CAREvent PAR 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 8f04463c-8d88-42d5-b1fb-6f262b90161c 38 fields · synced Jun 8, 2026