Cordella Sensor Delivery Kit

GUDID 00850008997006

The Cordella Pulmonary Artery Sensor System is designed for on-demand measurement of pulmonary artery pressure from the patient’s home. Cordella Sensor Delivery Kit consists of the Cordella PA Sensor and Delivery System which are components of the Cordella Pulmonary Artery Sensor System. Cordella PA Sensor The Cordella Sensor is a small implant that resides permanently in the patient’s right pulmonary artery. The Cordella Sensor does not contain batteries or active electrical components. The Cordella Sensor is not made with natural rubber latex. Delivery System The Delivery System is a catheter with a pre-loaded Cordella Sensor at the distal end and is used to implant the Cordella Sensor into the right pulmonary artery. The Delivery System comprises a stability sheath, torque catheter, handle, torque luer, and side port. Implantation of the Cordella Sensor using the Delivery System is designed to be performed during right heart catheterization through venous access. The Stability Sheath contains a marker band at the distal end to aid in visualization under fluoroscopy. The Delivery System is not made with natural rubber latex.

Endotronix, Inc.

Implantable pulmonary artery pressure monitoring system
Primary Device ID00850008997006
NIH Device Record Key59dfdbb6-125d-49ee-b1fe-2949702289c8
Commercial Distribution StatusIn Commercial Distribution
Brand NameCordella Sensor Delivery Kit
Version Model Number100303-05
Company DUNS806850835
Company NameEndotronix, Inc.
Device Count1
DM Exempttrue
Pre-market Exemptfalse
MRI Safety StatusMR Conditional
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numbertrue
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1 888 512 5595
Emailsupport@endotronix.com
Phone+1 888 512 5595
Emailsupport@endotronix.com
Phone+1 888 512 5595
Emailsupport@endotronix.com
Phone+1 888 512 5595
Emailsupport@endotronix.com
Phone+1 888 512 5595
Emailsupport@endotronix.com
Phone+1 888 512 5595
Emailsupport@endotronix.com
Phone+1 888 512 5595
Emailsupport@endotronix.com
Phone+1 888 512 5595
Emailsupport@endotronix.com
Phone+1 888 512 5595
Emailsupport@endotronix.com
Phone+1 888 512 5595
Emailsupport@endotronix.com
Phone+1 888 512 5595
Emailsupport@endotronix.com
Phone+1 888 512 5595
Emailsupport@endotronix.com
Phone+1 888 512 5595
Emailsupport@endotronix.com
Phone+1 888 512 5595
Emailsupport@endotronix.com
Phone+1 888 512 5595
Emailsupport@endotronix.com
Phone+1 888 512 5595
Emailsupport@endotronix.com
Phone+1 888 512 5595
Emailsupport@endotronix.com

Operating and Storage Conditions

Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry and out of sunlight.
Storage Environment TemperatureBetween 58 Degrees Fahrenheit and 85 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry and out of sunlight.
Storage Environment TemperatureBetween 58 Degrees Fahrenheit and 85 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry and out of sunlight.
Storage Environment TemperatureBetween 58 Degrees Fahrenheit and 85 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry and out of sunlight.
Storage Environment TemperatureBetween 58 Degrees Fahrenheit and 85 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry and out of sunlight.
Storage Environment TemperatureBetween 58 Degrees Fahrenheit and 85 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry and out of sunlight.
Storage Environment TemperatureBetween 58 Degrees Fahrenheit and 85 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry and out of sunlight.
Storage Environment TemperatureBetween 58 Degrees Fahrenheit and 85 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry and out of sunlight.
Storage Environment TemperatureBetween 58 Degrees Fahrenheit and 85 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry and out of sunlight.
Storage Environment TemperatureBetween 58 Degrees Fahrenheit and 85 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry and out of sunlight.
Storage Environment TemperatureBetween 58 Degrees Fahrenheit and 85 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry and out of sunlight.
Storage Environment TemperatureBetween 58 Degrees Fahrenheit and 85 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry and out of sunlight.
Storage Environment TemperatureBetween 58 Degrees Fahrenheit and 85 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry and out of sunlight.
Storage Environment TemperatureBetween 58 Degrees Fahrenheit and 85 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry and out of sunlight.
Storage Environment TemperatureBetween 58 Degrees Fahrenheit and 85 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry and out of sunlight.
Storage Environment TemperatureBetween 58 Degrees Fahrenheit and 85 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry and out of sunlight.
Storage Environment TemperatureBetween 58 Degrees Fahrenheit and 85 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry and out of sunlight.
Storage Environment TemperatureBetween 58 Degrees Fahrenheit and 85 Degrees Fahrenheit

Device Identifiers

Device Issuing AgencyDevice ID
GS100850008997006 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MOMSystem, Hemodynamic, Implantable

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-08-22
Device Publish Date2024-08-14

Devices Manufactured by Endotronix, Inc.

00850008997006 - Cordella Sensor Delivery Kit2024-08-22The Cordella Pulmonary Artery Sensor System is designed for on-demand measurement of pulmonary artery pressure from the patient’s home. Cordella Sensor Delivery Kit consists of the Cordella PA Sensor and Delivery System which are components of the Cordella Pulmonary Artery Sensor System. Cordella PA Sensor The Cordella Sensor is a small implant that resides permanently in the patient’s right pulmonary artery. The Cordella Sensor does not contain batteries or active electrical components. The Cordella Sensor is not made with natural rubber latex. Delivery System The Delivery System is a catheter with a pre-loaded Cordella Sensor at the distal end and is used to implant the Cordella Sensor into the right pulmonary artery. The Delivery System comprises a stability sheath, torque catheter, handle, torque luer, and side port. Implantation of the Cordella Sensor using the Delivery System is designed to be performed during right heart catheterization through venous access. The Stability Sheath contains a marker band at the distal end to aid in visualization under fluoroscopy. The Delivery System is not made with natural rubber latex.
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