TwitchView Large Electrode TVLEA025

GUDID 00850023319180

BLINK DEVICE COMPANY

Block-monitoring peripheral nerve electrical stimulation system
Primary Device ID00850023319180
NIH Device Record Keyd7d88d96-4637-4d9c-a515-ed70b1245b91
Commercial Distribution StatusIn Commercial Distribution
Brand NameTwitchView Large Electrode
Version Model NumberTVLEA025 Large Electrode
Catalog NumberTVLEA025
Company DUNS105714027
Company NameBLINK DEVICE COMPANY
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 Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone(206) 708-6043
Emailcontact@blinkdc.com
Phone(206) 708-6043
Emailcontact@blinkdc.com
Phone(206) 708-6043
Emailcontact@blinkdc.com
Phone(206) 708-6043
Emailcontact@blinkdc.com
Phone(206) 708-6043
Emailcontact@blinkdc.com
Phone(206) 708-6043
Emailcontact@blinkdc.com
Phone(206) 708-6043
Emailcontact@blinkdc.com
Phone(206) 708-6043
Emailcontact@blinkdc.com
Phone(206) 708-6043
Emailcontact@blinkdc.com
Phone(206) 708-6043
Emailcontact@blinkdc.com
Phone(206) 708-6043
Emailcontact@blinkdc.com
Phone(206) 708-6043
Emailcontact@blinkdc.com
Phone(206) 708-6043
Emailcontact@blinkdc.com
Phone(206) 708-6043
Emailcontact@blinkdc.com
Phone(206) 708-6043
Emailcontact@blinkdc.com
Phone(206) 708-6043
Emailcontact@blinkdc.com
Phone(206) 708-6043
Emailcontact@blinkdc.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100850023319180 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

KOIStimulator, Nerve, Peripheral, Electric

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-11-15
Device Publish Date2024-11-07

Devices Manufactured by BLINK DEVICE COMPANY

00850023319005 - TwitchView Medium Electrode2024-11-15
00850023319029 - TwitchView™2024-11-15 A reusable electrical cable that connects the TwitchView™ monitor to the single-use electrode array.
00850023319036 - TwitchView Small Electrode2024-11-15
00850023319098 - TwitchView2 Monitor2024-11-15
00850023319104 - TwitchView2 Charging Dock2024-11-15
00850023319111 - TwitchView2 Patient Cable 14'2024-11-15
00850023319173 - TwitchView2 Patient Cable 20'2024-11-15
00850023319180 - TwitchView Large Electrode2024-11-15
00850023319180 - TwitchView Large Electrode2024-11-15

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