Identity
- Trade Name
- CARevent ALS FDA UDI
- Generic Name
- Pulmonary resuscitator, pneumatic, reusable FDA UDI
- Device Name
- CAREvent ALS kit 01CV3212 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. FDA UDI
- Model / Reference
- 01CV3212 FDA UDI
- Description
- CAREvent ALS kit 01CV3212 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. FDA UDI
Identifiers
- Catalog Number
- 01CV3212 FDA UDI
- Primary DI / UDI-DI
- 07540195025141 FDA UDI
- GMDN Term
- Pulmonary resuscitator, pneumatic, reusable FDA UDI
Classification
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
Yes
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Pulmonary resuscitator, pneumatic, reusable
CARevent ALS by O-Two Medical Technologies Inc — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Pulmonary resuscitator, pneumatic, reusable.
- SILICONE ADULT 1600ML RESUSCITATOR W/ POP-OFF 60CM H2O — BESMED HEALTH BUSINESS CORP. · Class II
- Pneupac — ICU MEDICAL, INC. · Class II
- Life Support Products — Allied Medical LLC · Class II
- Puffin Lite Infant Resuscitator — INTERNATIONAL BIOMEDICAL, LTD. · Class II
- SILICONE INFANT 280ML RESUSCITATOR W/ POP-OFF 40CM H2O — BESMED HEALTH BUSINESS CORP. · Class II
- SILICONE ADULT 1700ML RESUSCITATOR W/O POP-OFF — BESMED HEALTH BUSINESS CORP. · Class II
- Life Support Products — Allied Medical LLC · Class II
- SILICONE INFANT 280ML RESUSCITATOR W/ POP-OFF 40CM H2O — BESMED HEALTH BUSINESS CORP. · Class II
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 | N/A | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- O-Two Medical Technologies Inc
Sources (1)
- FDA UDI bd3c2e38-6159-4d53-beb2-44c719d01378 36 fields · synced May 30, 2026