respistim R Stimulation Lead

GUDID 00857688007063

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

RESPICARDIA, INC.

Transvenous phrenic nerve electrical stimulation control unit

• Primary Device ID: 00857688007063
• NIH Device Record Key: 033ff60c-80f7-451e-91b3-3b1a3d6829c2
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: respistim R Stimulation Lead
• Version Model Number: 3102
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00857688007063 [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: 2
• Public Version Date: 2018-07-06
• Device Publish Date: 2018-04-30

On-Brand Devices [respistim R Stimulation Lead]

• 00857688007070: Respiratory stimulation lead. respistim R, 60 cm; 35 mm distal spring length; 20 mm distal coil
• 00857688007063: Respiratory stimulation lead; respistim R, 60cm; 25mm distal spring length; 24 mm distal coil di