Identity
- Trade Name
- SAVe II+ Simplified Automated Ventilator FDA UDI
- Generic Name
- Transport electric ventilator FDA UDI
- Device Name
- The AutoMedx SAVe II+ ventilator is a small, extremely durable, portable mechanical ventilator designed to provide lifesaving mechanical ventilation in prehospital, aeromedical, field hospital and hospital settings. The SAVe II+ is not a full featured ICU ventilator, however, it can play a significant role in extending a hospital’s surge capabilities during a pandemic or mass casualty situation or adult patients weighing at least 45kg. The easy-to-use, portability and long battery life, make the SAVe II+ well suited to provide lifesaving mechanical ventilation to the developing world, field hospitals, or other environments where there is a lack of equipment. And the design of the SAVe II+ maximizes safe and effective use for those with minimal training. FDA UDI
- Model / Reference
- 01 FDA UDI
- Description
- The AutoMedx SAVe II+ ventilator is a small, extremely durable, portable mechanical ventilator designed to provide lifesaving mechanical ventilation in prehospital, aeromedical, field hospital and hospital settings. The SAVe II+ is not a full featured ICU ventilator, however, it can play a significant role in extending a hospital’s surge capabilities during a pandemic or mass casualty situation or adult patients weighing at least 45kg. The easy-to-use, portability and long battery life, make the SAVe II+ well suited to provide lifesaving mechanical ventilation to the developing world, field hospitals, or other environments where there is a lack of equipment. And the design of the SAVe II+ maximizes safe and effective use for those with minimal training. FDA UDI
Identifiers
- Catalog Number
- 70111H-US FDA UDI
- Primary DI / UDI-DI
- M68970111HUS010 FDA UDI
- FDA Product Code
- BTL FDA UDI
- GMDN Term
- Transport electric ventilator FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 868.5925 FDA UDI
- 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: Transport electric ventilator
SAVe II+ Simplified Automated Ventilator by Safeguard Us Operating, Llc — Class II — 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 II | Pending data |
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Manufacturer
- Manufacturer
- Safeguard Us Operating, Llc
Sources (1)
- FDA UDI f8338403-4d93-4d2a-b1c0-c687b9573b0e 34 fields · synced May 30, 2026