Identity
- Trade Name
- Rescue Breather FDA UDI
- Generic Name
- Cardiopulmonary resuscitation mask, single-use FDA UDI
- Device Name
- Rescue Breather® CPR Pocket Ventilator provides the rescuer with a safe and effective means to perform life saving expired air resuscitation while offering maximum protection from the potential risks of disease transfer for both the patient and the rescuer.The Rescue Breather® CPR Pocket Ventilator comes standard with a disposable Low-Resistance Clear One-Way-Valve with built-in 3M Filtrete® Filter, protected Oxygen inlet, adjustable Head Strap, pair of “Latex Free” Nitrile Gloves, Instructions leaflet and Clam Shell Carrying Case. FDA UDI
- Model / Reference
- 01PV1503W FDA UDI
- Description
- Rescue Breather® CPR Pocket Ventilator provides the rescuer with a safe and effective means to perform life saving expired air resuscitation while offering maximum protection from the potential risks of disease transfer for both the patient and the rescuer.The Rescue Breather® CPR Pocket Ventilator comes standard with a disposable Low-Resistance Clear One-Way-Valve with built-in 3M Filtrete® Filter, protected Oxygen inlet, adjustable Head Strap, pair of “Latex Free” Nitrile Gloves, Instructions leaflet and Clam Shell Carrying Case. FDA UDI
Identifiers
- Catalog Number
- 01PV1503W-CS FDA UDI
- Primary DI / UDI-DI
- 07540195056510 FDA UDI
- FDA Product Code
- KGB FDA UDI
- GMDN Term
- Cardiopulmonary resuscitation mask, single-use FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 868.5570 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Cardiopulmonary resuscitation mask, single-use
Rescue Breather by O-Two Medical Technologies Inc — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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 | Class I | Pending data |
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Manufacturer
- Manufacturer
- O-Two Medical Technologies Inc
Sources (1)
- FDA UDI d01d082d-793c-4032-9a4e-12c1b4532edb 36 fields · synced May 30, 2026