CAREvent MRI
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Basic Information
- Brand Name
- CAREvent MRI
- Primary DI
- 07540195030183
- Version / Model
- 01CV7000
- Catalog Number
- 01CV7000
- Company Name
- O-Two Medical Technologies Inc
- Labeler DUNS
- 206449154
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2015-10-23
- Public Version
- 3
- Public Version Date
- 2018-07-06
- Public Version Status
- Update
- Public Device Record Key
- 16d0f66f-a9c6-4241-a426-2081a0c55d20
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.
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- MR Conditional
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- Yes
- Has Lot/Batch Number
- No
- Has Manufacturing Date
- Yes
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| BTL | Ventilator, Emergency, Powered (Resuscitator) | Anesthesiology | 868.5925 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 41148 | Portable pneumatic ventilator | A 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). | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 07540195030183 | GS1 | ||||
| Direct Marking | 07540195030176 | GS1 |
Customer Contacts
- Phone
- 1-800-387-3405
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K051469 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Weight | 6.25 | Pound | |
| Height | 4.3 | Inch | |
| Width | 6.5 | Inch | |
| Length | 9.25 | Inch |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- -40 – 60 Degrees Celsius