DEVICE: Avery Breathing Pacemaker System (00850252006035)

Device Identifier (DI) Information

Avery Breathing Pacemaker System
External Antenna
In Commercial Distribution
902A
Avery Biomedical Devices Inc
00850252006035
GS1

1
064726441 *Terms of Use
(902A) 1.0 m Lead Length
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Device Characteristics

Labeling does not contain MRI Safety Information
No
Yes
Yes
Yes
No
No
No
No

GMDN

[?]

GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. The copyright and database rights in the original GMDN materials are owned by The GMDN Agency Ltd 2005-2023. Used under licence from The GMDN Agency Ltd.

GMDN Term Code GMDN Term Name GMDN Term Definition GMDN Term Status [?] Implantable?
35652 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.
Active true
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FDA Product Code

[?]
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 005
No CLOSE

Sterilization

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

[?]
Storage and Handling
No storage/handling found
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Clinically Relevant Size

[?]
Size Type Text
No Device Sizes
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Device Record Status

ed79c29b-321a-4581-8d84-4f352c9cde90
July 06, 2018
3
January 23, 2015
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Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]
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

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

[?]
Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]
No
No
None
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Production Identifier(s) in UDI

[?]
Yes
No
No
Yes
No CLOSE

Customer Contact

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