FDA.reportPublic FDA data

TOF-ES_B

Primary DI
03665023000504
Brand
TOF-ES_B
Company
IDMED
Model
TOF-ES_B
Catalog number
TOF-ES_B
Device description
Eyebrow sensor and electrodes connector
Published
2020-03-20
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true

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
K172690000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K172690000ToFscanIdmed2018-05-31KOI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
03665023000504PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
03665023000504036650230005043665023000504

GMDN Terms#

Term, Definition table
TermDefinition
Neuromuscular transmission electrical skin sensorA non-sterile device intended to detect electrical neuromuscular transmission (NMT) signals, from an array of neuromuscular electrodes attached to the surface of the skin of the hand and forearm, or the foot, that are subsequently conducted through an NMT sensor cable to a patient monitoring module to assess the degree of neuromuscular block in a patient. It is typically used for applications when the hand alone cannot be used as the measurement site. This is a reusable device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
260233256
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
03665023001112CuffGuardCG-TUB12025-12-19
03665023000535WiTOFWiTOF-MUWiTOF-MU2025-12-19
03665023000542WiTOFWiTOF-MU2025-12-19
03665023000559WiTOFWiTOF-S2025-12-19
03665023000566WiTOFWiTOF2025-12-19
03665023000573WiTOFWiTOF-FS2025-12-19
03665023000610WiTOFWiTOF-DEMO2025-12-19
03665023000948CuffGuardCG-MU_ID2025-12-19
03665023000955CuffGuardCG-MU_DR2025-12-19
03665023000962CuffGuardPWR5-U_EU2025-12-19
03665023000979CuffGuardPWR5-U_UK2025-12-19
03665023000986CuffGuardPWR5-U_US2025-12-19
03665023000993CuffGuardPWR5-U_TI2025-12-19
03665023001020CuffGuardCG-KIT_ID2025-12-19
03665023001068CuffGuardCG-TUB12025-12-19
03665023002515CuffGuardPWR5-U_TI2025-12-19
03665023002522CuffGuardPWR5-U_EU2025-12-19
03665023002539CuffGuardPWR5-U_UK2025-12-19
03665023002546CuffGuardPWR5-U_US2025-12-19
03665023000030TOF-MUTOF-MUTOF-MU2018-07-13

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