FDA.report

CAREvent ATV+

Primary DI
07540195030121
Brand
CAREvent ATV+
Company
O-Two Medical Technologies Inc
Model
01CV6000
Catalog number
01CV6000
Device description
CAREvent ATV+ is pneumatically powered, time/volume cycled, intermittent positive pressure patient ventilators specifically designed for use by traine
Published
2015-10-23
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Related Records

Contact Domains

Product Codes

CodeName
BTLVentilator, Emergency, Powered (Resuscitator)

Product Code Classifications

CodeDeviceSpecialtyClass
BTLVentilator, Emergency, Powered (Resuscitator)Anesthesiology2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
07540195030114Direct MarkingGS10
07540195030121PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
07540195030114075401950301147540195030114
07540195030121075401950301217540195030121

GMDN Terms

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

TypeValueUnit
Height4.3Inch
Length9.25Inch
Weight6.25Pound
Width6.5Inch

Storage And Handling

TypeLowHighCondition
Storage Environment Temperature-40 Degrees Celsius60 Degrees Celsius

Sterilization Methods

Method

Contacts

PhoneEmail
1-800-387-3405cs@otwo.com

Regulatory Flags

DUNS number
206449154
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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