CirQPOD Intrathoracic Pressure Regulator

Primary DI
M5921224150000
Brand
CirQPOD Intrathoracic Pressure Regulator
Company
ADVANCED CIRCULATORY SYSTEMS INC
Model
12-2415-000
Device description
The CirQPOD Intrathoracic Pressure Regulator (IPR) System provides IPR therapy, intended to increase circulation and blood pressure in non-spontaneously breathing patients.The CirQPOD employs a single use, disposable blower device connected to the CirQPOD Motor - used in combination with a ventilator source - to deliver a positive pressure breath (ventilation) to a patient. The CirQPOD’s mechanism of action derives from the physiologic principle that lower intrathoracic pressure will increase venous return to the heart. The increase in venous return results in increased cardiac output, circulation, and blood pressure.When inserted within a standard respiratory circuit between the patient and a ventilation source, the CirQPOD generates negative pressure during the expiratory phase to create sub-atmospheric intrathoracic pressure between the periods of positive pressure ventilations.
Published
2018-08-23
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true

Product Codes#

Code, Name table
CodeName
BWFSpirometer, Therapeutic (Incentive)

Product Code Classifications#

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K172388000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K172388000VPOD ITPRAdvanced Circulatory System, A Wholly Owned Subsidiary OF2017-12-22BWF

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
M5921224150000PrimaryHIBCC0

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
Serial number
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
M5921207070000ResQGARD FM Kit 12-0707-0002018-08-23
M5921202420000ResQPOD ITD 1012-0242-0002016-11-11
M5921208250001ResQCPR System12-0825-0002016-01-19

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