FDA.reportPublic FDA data

ResQGARD FM Kit

Primary DI
M5921207070000
Brand
ResQGARD FM Kit
Company
ADVANCED CIRCULATORY SYSTEMS INC
Model
12-0707-000
Device description
The ResQGARD ITD 7 is indicated for the temporary increase in blood circulation. The device is used to enhance circulation by lowering intrathoracic pressure in spontaneously breathing patients who experience poor circulation and low blood flow that may be indicated by low blood pressure. The device functions by adding selective inspiratory airway impedance within the respiratory circuit. Airway impedance is experienced when the patient spontaneously inspires. Expiratory impedance is negligible.
Published
2018-08-23
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true
Single use
true

Product Codes#

Code, Name table
CodeName
BWFSpirometer, Therapeutic (Incentive)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
BWFSpirometer, Therapeutic (Incentive)Anesthesiology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
M5921207070000PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Cardiopulmonary resuscitation kit, reusableA collection of items in a portable case intended for cardiopulmonary resuscitation (e.g., airway tubes, face masks, resuscitator). It is typically placed in a convenient location in public buildings and in emergency medical services (EMS) vehicles for quick access in emergency situations. This is a reusable device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
140320396
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
M5921224150000CirQPOD Intrathoracic Pressure Regulator12-2415-0002018-08-23
M5921202420000ResQPOD ITD 1012-0242-0002016-11-11
M5921208250001ResQCPR System12-0825-0002016-01-19

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