CAREvent MRI

Primary DI
07540195030183
Brand
CAREvent MRI
Company
O-Two Medical Technologies Inc
Model
01CV7000
Catalog number
01CV7000
Device 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.
Published
2015-10-23
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
BTLVentilator, Emergency, Powered (Resuscitator)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
BTLVentilator, Emergency, Powered (Resuscitator)Anesthesiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K051469000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K051469000CAREVENT ATV+ AND CAREVENT MRIO-Two Medical Technologies, Inc.2005-09-28BTL

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07540195030176Direct MarkingGS10
07540195030183PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07540195030176075401950301767540195030176
07540195030183075401950301837540195030183

GMDN Terms#

Term, Definition table
TermDefinition
Portable pneumatic ventilatorA pneumatically-powered, lightweight device that is easily moved/mounted and used to provide long-term alveolar ventilation support for patients who do not require complex critical care ventilation. It typically uses positive pressure to deliver gas to the lungs at normal breathing rates and tidal volumes through an endotracheal (ET) tube, tracheostomy cannula, or mask. It includes a control system and alarms, sometimes with additional features (e.g., humidification). Several methods of cycling and ventilation modes may be used. It is typically used in the home, but may also be used in an extended care facility, and/or by emergency medical services (EMS).

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Height4.3Inch
Length9.25Inch
Weight6.25Pound
Width6.5Inch

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature-40 Degrees Celsius60 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
1-800-387-3405cs@otwo.com

Regulatory Flags#

DUNS number
206449154
Device count
1
Serial number
true
Manufacturing date on label
true

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Primary DI, Brand, Model table
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07540195005129O-Two01CV801001CV8010-CS2019-05-31
07540195071308O-Two02RT101002RT1010-CS2019-10-31
07540195071322O-Two02RT101202RT1012-CS2019-10-31

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