FDA.reportPublic FDA data

SAVe II+ Simplified Automated Ventilator

Primary DI
M68970110HMU020
Brand
SAVe II+ Simplified Automated Ventilator
Company
Safeguard US Operating, LLC
Model
02
Catalog number
70110H-MU
Device description
(Metric Version) 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
2025-11-20
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

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
M68970110HMU020PrimaryHIBCC0

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.

Contacts#

Phone, Email table
PhoneEmail
855-428-6074sales@safeguardmedical.com

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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M68980801D150Fresh Whole Blood Donor Transfusion Set1580-801-D2025-03-04
M68980801R110Fresh Whole Blood Recipient Set1180-801-R2025-03-04
M68980100140INTRAVENOUS INFUSION STARTER SET 1480-1002024-12-27
M6898010020030INTRAVENOUS INFUSION STARTER SET Case of 200380-100-202024-12-27
M68980801R100Fresh Whole Blood Recipient Set1080-801-R2024-12-16
M68980801050Fresh Whole Blood Transfusion Set580-8012022-08-09
M6898141003030Maritime First Aid Resupply - Advanced0381-410-032026-04-07

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Primary DI, Brand, Company table
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