System Destination Kit, ALS CE

GUDID 00852184003076

Synapse Biomedical, Inc.

Intramuscular diaphragm/phrenic nerve electrical stimulation system
Primary Device ID00852184003076
NIH Device Record Key8638c8dc-f3b7-48c6-8793-5076932341dc
Commercial Distribution StatusIn Commercial Distribution
Brand NameSystem Destination Kit, ALS CE
Version Model Number20-0064
Company DUNS138432070
Company NameSynapse Biomedical, Inc.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kittrue
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100852184003076 [Primary]

FDA Product Code

OIRDiaphragmatic/Phrenic Nerve Laparoscopically-Implanted Stimulator

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2018-03-29
Device Publish Date2014-09-24

Devices Manufactured by Synapse Biomedical, Inc.

00852184003588 - Disposable Electrode Delivery Tool2021-03-24
00852184003618 - 2 Pack, Electrode Delivery Tool Kit2021-03-24
00852184003007 - NeuRx Diaphragm Pacing System2018-03-29
00852184003014 - NeuRx DPS™ System Kit2018-03-29
00852184003021 - NeuRx DPS™ System Kit, ALS CE2018-03-29
00852184003038 - NeuRx DPS™ Surgical Kit, HDE2018-03-29
00852184003045 - NeuRx DPS Patient Kit2018-03-29
00852184003052 - NeuRx DPS™ Patient Kit, 1 EPG2018-03-29

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