Avery Breathing Pacemaker System 902A

GUDID 00850252006035

(902A) 1.0 m Lead Length

Avery Biomedical Devices Inc

Extramuscular diaphragm/phrenic nerve electrical stimulation system

• Primary Device ID: 00850252006035
• NIH Device Record Key: ed79c29b-321a-4581-8d84-4f352c9cde90
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Avery Breathing Pacemaker System
• Version Model Number: External Antenna
• Catalog Number: 902A
• Company DUNS: 064726441
• Company Name: Avery Biomedical Devices Inc
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• 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: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 631-864-1600
• Email: info@averybiomedical.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850252006035 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Approval: P860026

FDA Product Code

• GZE: Implanted Diaphragmatic/Phrenic Nerve Stimulator

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2015-01-23

On-Brand Devices [Avery Breathing Pacemaker System]

• 00850252006059: Transtelephonic Monitor
• 00850252006042: (902A) 2.0 m Lead Length
• 00850252006035: (902A) 1.0 m Lead Length
• 00850252006028: Neurostimulator Electrode Implant
• 00850252006011: Neurostimulator Receiver Implant
• 00850252006004: Neurostimulator Transmitter
• 00850252006066: Digital Transmitter for the Avery Breathing Pacemaker System