FDA.reportPublic FDA data

TwitchView Medium Electrode

Primary DI
00850023319005
Brand
TwitchView Medium Electrode
Company
BLINK DEVICE COMPANY
Model
TVMEA025 Medium Electrode
Catalog number
TVMEA025
Published
2024-11-07
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true
Single use
true

Contact Domains#

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
00850023319005PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850023319005008500233190058500233190050850023319005

GMDN Terms#

Term, Definition table
TermDefinition
Block-monitoring peripheral nerve electrical stimulation systemAn assembly of battery-powered devices designed to apply electrical stimuli to a peripheral nerve (e.g., the ulnar or lower extremity nerve) to assess the adequacy of neuromuscular block during surgery, and its reversal during the recovery period. The system typically uses four kinds of stimulation: twitch, train-of-four, tetanic, and double burst. It typically includes conventional electrocardiographic electrodes and/or bipolar surface electrodes (ball electrodes), and a pulse generator.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
(206) 708-6043contact@blinkdc.com

Regulatory Flags#

DUNS number
105714027
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
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
00860298001079TwitchView™Cable Assembly 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
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
04255629200409Temperature sensor TOF3DMIPM Mammendorfer Institut für Physik und Medizin GmbHKOI2023-07-10