respistim LQS Stimulation Lead, Inline Connector

GUDID 00857688007483

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

RESPICARDIA, INC.

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• Primary Device ID: 00857688007483
• NIH Device Record Key: 29aa8e88-d7c7-4c0f-b002-991f3ebfb138
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: respistim LQS Stimulation Lead, Inline Connector
• Version Model Number: 4665
• 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@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	00857688007483 [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

On-Brand Devices [respistim LQS Stimulation Lead, Inline Connector]

• 00857688007490: Respiratory stimulation lead. respistim LQS with additional proximal tubing, 85cm; quadpolar; d
• 00857688007483: Respiratory stimulation lead. respistim LQS, additional proximal tubing, 65cm; quadpolar; dista