Lead Test Adaptor, remede EL-X

GUDID 00857688007421

Lead Test Adaptor, remede EL-X, for use with Inline Connector Leads

RESPICARDIA, INC.

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

• Primary Device ID: 00857688007421
• NIH Device Record Key: 5b2c1762-4bc1-422f-a447-0a9c7da073fe
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Lead Test Adaptor, remede EL-X
• Version Model Number: 1007
• 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: false
• 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@zoll.com
• Phone: +19525404471
• Email: mlynn@zoll.com
• Phone: +19525404471
• Email: mlynn@zoll.com
• Phone: +19525404471
• Email: mlynn@zoll.com
• Phone: +19525404471
• Email: mlynn@zoll.com
• Phone: +19525404471
• Email: mlynn@zoll.com
• Phone: +19525404471
• Email: mlynn@zoll.com
• Phone: +19525404471
• Email: mlynn@zoll.com
• Phone: +19525404471
• Email: mlynn@zoll.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00857688007421 [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: 2021-08-30
• Device Publish Date: 2021-08-20

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: 2021-08-30Lead Test Adaptor, remede EL-X, for use with Inline Connector Leads
• 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