FDA.reportPublic FDA data

TwitchView™

Primary DI
00860298001079
Brand
TwitchView™
Company
BLINK DEVICE COMPANY
Model
Cable Assembly v1
Device description
A reusable electrical cable that connects the TwitchView™ monitor to the single-use electrode array.
Published
2018-09-05
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
KOIStimulator, Nerve, Peripheral, Electric

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KOIStimulator, Nerve, Peripheral, ElectricAnesthesiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K172843000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K172843000TwitchView SystemBlink Device Corporation2018-03-29KOI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00860298001079PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00860298001079008602980010798602980010790860298001079

GMDN Terms#

Term, Definition table
TermDefinition
Electrical-only medical device connection cable, reusableA non-patient-contact, insulated, electrical cord with a connector (plug) at both ends designed to transmit electrical power and/or signal (data) between medical devices (e.g., to connect a lead, electrical catheter, handpiece, or monitor to a parent device). It is not intended to connect directly to patient-worn electrodes (i.e., it is not a lead), is not intended to connect to the mains (i.e., not a mains power cable), does not generate any type of power and/or signal, and has no additional non-electrical conducting or processing functionality. This is a reusable device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
105714027
Device count
1
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850023319005TwitchView Medium ElectrodeTVMEA025 Medium ElectrodeTVMEA0252024-11-07
00850023319029TwitchView™Cable Assembly v1 14'TVCAB032024-11-07
00850023319036TwitchView Small ElectrodeTVSEA025 Small ElectrodeTVSEA0252024-11-07
00850023319098TwitchView2 MonitorTVMON02TVMON022024-11-07
00850023319104TwitchView2 Charging DockTVCS02TVCS022024-11-07
00850023319111TwitchView2 Patient Cable 14'TVCAB04TVCAB042024-11-07
00850023319173TwitchView2 Patient Cable 20'TVCAB05TVCAB052024-11-07
00850023319180TwitchView Large ElectrodeTVLEA025 Large ElectrodeTVLEA0252024-11-07
00860298001048TwitchView™Charging Dock v12018-09-05
00860298001093TwitchView™Cable Assembly v1 12'2019-09-06
00860298001055TwitchView™Electrode v12018-09-05
00860298001031TwitchView™Monitor v12018-09-05
00860298001086TwitchView™Electrode v12018-09-05

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00840682147811CARESCAPE SoftwareGE Healthcare Finland OyKOI2026-04-15
03665023000535WiTOFIDMEDKOI2025-12-19
03665023000542WiTOFIDMEDKOI2025-12-19
03665023000559WiTOFIDMEDKOI2025-12-19
03665023000566WiTOFIDMEDKOI2025-12-19
03665023000573WiTOFIDMEDKOI2025-12-19
03665023000610WiTOFIDMEDKOI2025-12-19
04255629200751Mechanomyography Sensor (MMG) for Neuromuscular Transmission Monitor TOF3DMIPM Mammendorfer Institut für Physik und Medizin GmbHKOI2025-11-21
00860012119660iTOFNERBIO PRIVATE LIMITEDKOI2025-02-05
00850023319005TwitchView Medium ElectrodeBLINK DEVICE COMPANYKOI2024-11-07
00850023319029TwitchView™BLINK DEVICE COMPANYKOI2024-11-07
00850023319036TwitchView Small ElectrodeBLINK DEVICE COMPANYKOI2024-11-07
00850023319098TwitchView2 MonitorBLINK DEVICE COMPANYKOI2024-11-07
00850023319104TwitchView2 Charging DockBLINK DEVICE COMPANYKOI2024-11-07
00850023319111TwitchView2 Patient Cable 14'BLINK DEVICE COMPANYKOI2024-11-07
00850023319173TwitchView2 Patient Cable 20'BLINK DEVICE COMPANYKOI2024-11-07
00850023319180TwitchView Large ElectrodeBLINK DEVICE COMPANYKOI2024-11-07
07350012440268TetraHubSenzime AB (Publ.)KOI2024-10-11
07350012440237TetraGraphSenzime AB (Publ.)KOI2024-10-03
07350012440169TetraSensSenzime AB (Publ.)KOI2024-04-26
07350012440183TetraSens PediatricSenzime AB (Publ.)KOI2024-04-26
07350012440244TetraSensitiveSenzime AB (Publ.)KOI2024-04-26
07350012440176TetraSensSenzime AB (Publ.)KOI2024-04-26
07350012440190TetraSens PediatricSenzime AB (Publ.)KOI2024-04-26
07350012440251TetraSensitiveSenzime AB (Publ.)KOI2024-04-26
07350012440206TetraSensitiveSenzime AB (Publ.)KOI2023-11-06
04255629200904EPSIMEDEPSIMED LLCKOI2023-10-25
04255629200423Eye adapter TOF3DMIPM Mammendorfer Institut für Physik und Medizin GmbHKOI2023-07-10
04255629200454Thumb adapter TOF3DMIPM Mammendorfer Institut für Physik und Medizin GmbHKOI2023-07-10
04255629200393TOF3D - Neuromuscular Transmission MonitorMIPM Mammendorfer Institut für Physik und Medizin GmbHKOI2023-07-10