DEVICE: Avery Breathing Pacemaker System (00850252006066)

Device Identifier (DI) Information

Avery Breathing Pacemaker System
NeurostimulatorTransmitter Digital
In Commercial Distribution
Spirit
Avery Biomedical Devices Inc
00850252006066
GS1

1
064726441 *Terms of Use
Digital Transmitter for the Avery Breathing Pacemaker System
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
Yes
Yes
No
No
No
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.
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FDA Product Code

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Product Code Product Code Name
GZE Implanted Diaphragmatic/Phrenic Nerve Stimulator
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
P860026 009
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Sterilization

No
No
Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

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Storage and Handling
Storage Environment Atmospheric Pressure: between 70 and 106 KiloPascal
Storage Environment Humidity: between 10 and 93 Percent (%) Relative Humidity
Storage Environment Temperature: between -25 and 70 Degrees Celsius
Handling Environment Humidity: between 10 and 93 Percent (%) Relative Humidity
Handling Environment Temperature: between -25 and 70 Degrees Celsius
Handling Environment Atmospheric Pressure: between 70 and 106 KiloPascal
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Clinically Relevant Size

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Size Type Text
No Device Sizes
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Device Record Status

a09cbc0c-61e1-4e02-bf61-e9b32713de0e
November 18, 2019
1
November 08, 2019
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Alternative and Additional Identifiers Additional Identifiers

Package DI

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Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
No Package DIs found
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Secondary DI

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Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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Unit of Use DI

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Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

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No
No
None
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Production Identifier(s) in UDI

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No
Yes
No
Yes
No CLOSE

Customer Contact

[?]
631-864-1600
info@averybiomedical.com
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