respistim LQS Stimulation Lead, Additional Proximal Tubing

GUDID 00857688007384

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

RESPICARDIA, INC.

Transvenous phrenic nerve electrical stimulation control unit Transvenous phrenic nerve electrical stimulation control unit

• Primary Device ID: 00857688007384
• NIH Device Record Key: e1c12559-b5eb-45e7-bbb0-848f9cf19c51
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: respistim LQS Stimulation Lead, Additional Proximal Tubing
• Version Model Number: 4165
• 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: true
• Lot Batch: true
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: true
• 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
• Phone: +19525404471
• Email: mlynn@respicardia.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00857688007384 [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: true

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-10-19
• Device Publish Date: 2020-10-09

Devices Manufactured by RESPICARDIA, INC.

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• 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