remede System Flexible Programming Wand

GUDID 00857688007339

remede System Flexible Programming Wand

RESPICARDIA, INC.

Transvenous phrenic nerve electrical stimulation control unit

• Primary Device ID: 00857688007339
• NIH Device Record Key: 64143e3c-5f9c-429a-94cc-4be0eba6fb39
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: remede System Flexible Programming Wand
• Version Model Number: 1004A-F
• Company DUNS: 027887663
• Company Name: RESPICARDIA, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Unsafe
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +19525404471
• Email: mlynn@respicardia.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00857688007339 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Approval: P160039

FDA Product Code

• PSR: Implanted Phrenic Nerve Stimulator For Central Sleep Apnea

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2018-07-06
• Device Publish Date: 2018-04-30

Devices Manufactured by RESPICARDIA, INC.

• 00857688007391 - remede EL System Implantable Pulse Generator IS-1: 2021-08-30 remede EL System, implantable pulse generator for phrenic nerve stimulation, IS-1 header
• 00857688007407 - remede EL-X System Implantable Pulse Generator Inline Connector: 2021-08-30 remede EL-X System, implantable pulse generator for phrenic nerve stimulation, inline connector header
• 00857688007414 - remede EL/EL-X External Pulse Generator: 2021-08-30 remede EL/EL-X external pulse generator
• 00857688007421 - Lead Test Adaptor, remede EL-X: 2021-08-30 Lead Test Adaptor, remede EL-X, for use with Inline Connector Leads
• 00857688007438 - respistim R Stimulation Lead, Inline Connector: 2021-08-30 Respiratory stimulation lead; respistim R, 60cm; 25mm distal spring length; 24 mm distal coil diameter; hexapolar; distal spiral
• 00857688007445 - respistim R Stimulation Lead, Inline Connector: 2021-08-30 Respiratory stimulation lead. respistim R, 60 cm; 35 mm distal spring length; 20 mm distal coil diameter; hexapolar; distal spi
• 00857688007452 - respistim R Stimulation Lead, Inline Connector: 2021-08-30 Respiratory stimulation lead; respistim R, 50cm; 25mm distal spring length; 24 mm distal coil diameter; hexapolar; distal spiral
• 00857688007469 - respistim R Stimulation Lead, Inline Connector: 2021-08-30 Respiratory stimulation lead. respistim R, 50 cm; 35 mm distal spring length; 20 mm distal coil diameter; hexapolar; distal spi