RESPICARDIA, INC.

Address:12400 Whitewater Dr Ste 150,Minnetonka,MN,55343,US

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Device Class

Class-1 (A medical device with low to moderate risk that requires general controls) Class-2 (A medical device with a moderate to high risk that requires special controls) Class-3 (A medical device with high risk that requires premarket approval) Class-U (Unclassified)

Product Code

Implanted Phrenic Nerve Stimulator For Central Sleep Apnea (PSR) (9) Catheter, Intravascular, Diagnostic (DQO) (1)

Premarket Exempt

Clear

remede System Implantable Pulse Generator - 00857688007001 Catalog Number :

Device Description : remede System, implantable pulse generator for phrenic nerve stimulation

Device Class : 3

Duns Number: 027887663

Premarket Exempt : No

Product Code : PSR

Prescription Use : Yes

Device Count : 1

respistim R Stimulation Lead - 00857688007063 Catalog Number :

Device Description : Respiratory stimulation lead; respistim R, 60cm; 25mm distal spring length; 24 m Respiratory stimulation lead; respistim R, 60cm; 25mm distal spring length; 24 mm distal coil diameter; hexapolar; distal spiral bias

Device Class : 3

Duns Number: 027887663

Premarket Exempt : No

Product Code : PSR

Prescription Use : Yes

Device Count : 1

respistim R Stimulation Lead - 00857688007070 Catalog Number :

Device Description : Respiratory stimulation lead. respistim R, 60 cm; 35 mm distal spring length; 2 Respiratory stimulation lead. respistim R, 60 cm; 35 mm distal spring length; 20 mm distal coil diameter; hexapolar; distal spiral bias

Device Class : 3

Duns Number: 027887663

Premarket Exempt : No

Product Code : PSR

Prescription Use : Yes

Device Count : 1

respistim LQS Stimulation Lead - 00857688007230 Catalog Number :

Device Description : Respiratory stimulation lead. respistim LQS, 65cm; quadpolar; distal bias

Device Class : 3

Duns Number: 027887663

Premarket Exempt : No

Product Code : PSR

Prescription Use : Yes

Device Count : 1

Respiguide Delivery System - 00857688007278 Catalog Number :

Device Description : Respiguide Delivery System, 35 cm Outer Guide Catheter with 120 degree bend Dist Respiguide Delivery System, 35 cm Outer Guide Catheter with 120 degree bend Distal shape; 65 cm Inner Angiographic Catheter with Straight Distal Shape

Device Class :

Duns Number: 027887663

Premarket Exempt : No

Product Code : DQO

Prescription Use : Yes

Device Count : 1

remede System Programmer - 00857688007315 Catalog Number :

Device Description : remede System Programmer for use with remede System implantable pulse generator

Device Class : 3

Duns Number: 027887663

Premarket Exempt : No

Product Code : PSR

Prescription Use : Yes

Device Count : 1

remede System Programming Wand - 00857688007322 Catalog Number :

Device Description : remede System Programmer Wand

Device Class : 3

Duns Number: 027887663

Premarket Exempt : No

Product Code : PSR

Prescription Use : Yes

Device Count : 1

remede System Flexible Programming Wand - 00857688007339 Catalog Number :

Device Description : remede System Flexible Programming Wand

Device Class : 3

Duns Number: 027887663

Premarket Exempt : No

Product Code : PSR

Prescription Use : Yes

Device Count : 1

remede System External Pulse Generator - 00857688007346 Catalog Number :

Device Description : remede System external pulse generator

Device Class : 3

Duns Number: 027887663

Premarket Exempt : No

Product Code : PSR

Prescription Use : Yes

Device Count : 1

respistim LQS Stimulation Lead, Additional Proximal Tubing - 00857688007384 Catalog Number :

Device Description : Respiratory stimulation lead. respistim LQS with additional proximal tubing, 65 Respiratory stimulation lead. respistim LQS with additional proximal tubing, 65cm; quadpolar; distal bias

Device Class : 3

Duns Number: 027887663

Premarket Exempt : No

Product Code : PSR

Prescription Use : Yes

Device Count : 1

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