Avery Breathing Pacemaker System E377-05

GUDID 00850252006028

Avery Biomedical Devices Inc

Extramuscular diaphragm/phrenic nerve electrical stimulation system
Primary Device ID00850252006028
NIH Device Record Key5514810b-792c-450f-8db0-0a08e0515c9b
Commercial Distribution StatusIn Commercial Distribution
Brand NameAvery Breathing Pacemaker System
Version Model NumberNeurostimulator Electrode Implant
Catalog NumberE377-05
Company DUNS064726441
Company NameAvery Biomedical Devices Inc
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Unsafe
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone631-864-1600
Emailinfo@averybiomedical.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100850252006028 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

GZEImplanted Diaphragmatic/Phrenic Nerve Stimulator

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00850252006028]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2015-01-23

On-Brand Devices [Avery Breathing Pacemaker System]

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

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