CAREvent ALS
Basic Information
- Brand Name
- CAREvent ALS
- Primary DI
- 07540195025127
- Version / Model
- 01CV3112
- Catalog Number
- 01CV3112
- 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
- 2015-10-26
- Public Version
- 3
- Public Version Date
- 2018-07-06
- Public Version Status
- Update
- Public Device Record Key
- f770346e-0e13-47a3-a9d1-acb739a515df
Device Description
CAREvent ALS kit 01CV3112 contains a CAREvent ALS resuscitator, a pressure regulator, and an aspirator in moulded case with a Yankauer Scution Tip with Tubing. CAREvent ALS hand held automatic resuscitator is pneumatically powered, time/volume cycled ventilatlatory resuscitator. It provides trained individuals with a safe and effective means of providing artificial ventilation during respiratory and cardiac arrest. The CAREvent ALS delivers automatic ventilation with controlled flow rates, airway pressure, tidal volume and frequencies. Patients are protected from over inflation and potential barotraumas by an audible Pressure Relief System. In addition, CAREvent ALS allows the breathing patient to “Demand Breathe” on 100% oxygen at their own rate and volume.
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- Yes
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- Yes
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 13366 | Pulmonary resuscitator, pneumatic, reusable | A device designed to provide or assist ventilation in a patient who is apnoeic or exhibits inadequate respiration through automatic pneumatic-driven pressure cycle functions. It is connected to a source of compressed oxygen (O2) and, if not entrained, medical air via oxygen/air terminal units or gas cylinder(s). It typically includes gas supply tubing, a breathing circuit with, e.g., a gas control modulator, gas connector(s), safety valves, and a flex connector to connect to a face mask or endotracheal (ET) tube. It is used in ambulances, intensive care units (ICU), during internal patient transfer, accident and emergency (A&E), and mass casualty incidents (MCI). This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 07540195025127 | GS1 |
Customer Contacts
- Phone
- 1-800-387-3405
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K991195 | 000 |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- -40 – 60 Degrees Celsius