FDA.reportPublic FDA data

SAVe II+ Simplified Automated Ventilator

Primary DI
M68970111HUS010
Brand
SAVe II+ Simplified Automated Ventilator
Company
Safeguard US Operating, LLC
Model
01
Catalog number
70111H-US
Device 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.
Published
2024-12-17
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
BTLVentilator, Emergency, Powered (Resuscitator)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
BTLVentilator, Emergency, Powered (Resuscitator)Anesthesiology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
M68970111HUS010PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Transport electric ventilatorAn electrically-powered device designed to provide automated, alveolar ventilatory support for patients during interhospital or intrahospital transport, and in emergency situations. It is typically a compact, lightweight, rugged device with internal batteries to power it during patient transport. It typically provides mandatory breaths at pre-set intervals (control mode), not allowing the patient to breathe spontaneously; operation in assist/control and/or synchronized intermittent mandatory ventilation (SIMV) modes is available in some types. It usually includes an airway pressure monitor and low and high pressure alarms; it may be used in ambulances, and in field hospitals.

Regulatory Flags#

DUNS number
118492643
Device count
1
Kit
true
Lot or batch
true
Serial number
true
Manufacturing date on label
true

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M6898810503020Patrol Officer IFAK Advanced0288-105-032018-09-20
M6898810502030Patrol Officer IFAK Intermediate0388-105-022020-01-06
M6898810503030Patrol Officer IFAK Advanced0388-105-032020-01-06
M689PBEFAK010Point Blank Enterprises Employee FAK - Private Label01PBEFAK2026-07-09
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