FDA.reportPublic FDA data

ResQPOD ITD 10

Primary DI
M5921202420000
Brand
ResQPOD ITD 10
Company
ADVANCED CIRCULATORY SYSTEMS INC
Model
12-0242-000
Device description
The ResQPOD ITD 10 is indicated for the temporary increase in blood circulation.
Published
2016-11-11
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Product Codes#

Code, Name table
CodeName
BWFSpirometer, Therapeutic (Incentive)
JOWSleeve, Limb, Compressible

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
BWFSpirometer, Therapeutic (Incentive)Anesthesiology2
JOWSleeve, Limb, CompressibleCardiovascular2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
M5921202420001PackageHIBCC10In Commercial Distribution
M5921202420002PackageHIBCC100In Commercial Distribution
M5921202420000PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Cardiopulmonary resuscitation impedance valve, inspiratoryA non-sterile valve intended to increase blood flow to the heart and brain of a patient during cardiopulmonary resuscitation (CPR) by selectively impeding inspiratory gases during the release phase of CPR resulting in increased negative pressure in the thorax, greater venous return to the heart, and increased blood flow during the next compression. It is designed to connect between a ventilation source (e.g., pulmonary resuscitator) and an airway adjunct (e.g., face mask, breathing tube) and is typically comprised of a valve diaphragm (e.g., silicone) with a ventilation port and supplemental features [e.g., safety mechanism, visual metronome (battery-powered)]. This is a single-use device.

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
M5921207070000ResQGARD FM Kit 12-0707-0002018-08-23
M5921224150000CirQPOD Intrathoracic Pressure Regulator12-2415-0002018-08-23
M5921208250001ResQCPR System12-0825-0002016-01-19

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Primary DI, Brand, Company table
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