DEVICE: Avery Breathing Pacemaker System (00850252006059)
Device Identifier (DI) Information
Avery Breathing Pacemaker System
Transtelephonic Monitor
In Commercial Distribution
TTM
Avery Biomedical Devices Inc
Transtelephonic Monitor
In Commercial Distribution
TTM
Avery Biomedical Devices Inc
No description.
Device Characteristics
Labeling does not contain MRI Safety Information | |
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No | |
Yes | |
Yes | |
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No |
GMDN
[?]GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.
GMDN Preferred Term Name | GMDN Definition |
---|---|
Extramuscular diaphragm/phrenic nerve electrical stimulation system | An assembly of battery-powered devices designed to provide ventilatory support to a patient with diaphragm dysfunction of neuromuscular origin through electrical stimulation of the phrenic nerve, to contract the diaphragm rhythmically and cause the patient to draw breath in a manner similar to natural breathing. It typically consists of an implanted receiver with electrodes that are placed around the patient's phrenic nerve, and an external transmitter for transmitting the stimulating pulses across the patient's skin to the implanted receiver. |
FDA Product Code
[?]Product Code | Product Code Name |
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GZE | Implanted Diaphragmatic/Phrenic Nerve Stimulator |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
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P860026 | 005 |
Sterilization
Storage and Handling
[?]Storage and Handling |
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No storage/handling found |
Clinically Relevant Size
[?]Size Type Text |
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No Device Sizes |
Device Record Status
2e50e793-2a2e-428a-8d3c-795d74fb637a
July 06, 2018
3
January 23, 2015
July 06, 2018
3
January 23, 2015
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
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No Package DIs found |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
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No Secondary DIs found |
Unit of Use DI
[?]
Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
631-864-1600
info@averybiomedical.com
info@averybiomedical.com