FDA.reportPublic FDA data

Eye adapter TOF3D

Primary DI
04255629200423
Brand
Eye adapter TOF3D
Company
MIPM Mammendorfer Institut für Physik und Medizin GmbH
Model
5750102
Catalog number
5750102
Published
2023-07-10
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
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
K212434000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K212434000Neuromuscular Transmission Monitor TOF3DMIPM Mammendorfer Institut für Physik und Medizin GmbH2022-05-05KOI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
EMIP57501025PreviousHIBCC0
04255629200423PrimaryGS10
04255629200416Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04255629200423042556292004234255629200423
04255629200416042556292004164255629200416

GMDN Terms#

Term, Definition table
TermDefinition
Sensor holder, single-useA device designed to hold (house) a sensor so that it is fixed (locked) in a stable position, including adhesive fixation. It will then allow for the holder and the attached sensor to be fastened to, e.g., the patient's body, another device, or a suitable place in the vicinity of use. This is a single-use device.

Contacts#

Phone, Email table
PhoneEmail
+49814592090info@mipm.com

Regulatory Flags#

DUNS number
324416379
Device count
50
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
EMIP51000430NIBP Pressure cuff 42 - 52 cmThigh 42 - 52 cm51000432019-11-11
04255629200751Mechanomyography Sensor (MMG) for Neuromuscular Transmission Monitor TOF3D575012657501262025-11-21
04255629200539Wireless ECG Sensor for Tesla M3Wireless ECG Sensor for Tesla M353000282023-12-13
EMIP53000280Wireless ECG Sensor for Tesla M3Wireless ECG Sensor for Tesla M353000282019-11-11
04255629200508MRI Patient Monitor TeslaDUOTeslaDUO17000012024-01-25
04255629200515TeslaDUO Remote Control510004751000472024-01-25
04255629200522Trolley TeslaDUO including MFITrolley TeslaDUO including MFI63000402024-01-25
04255629200553Wireless Pulse Oximetry Sensor for TeslaDUOWireless Pulse Oximetry Sensor for TeslaDUO50101012024-01-25
04255629200362SpO2 Finger Adapter M-Flex501004950100492023-12-14
04255629200386SpO2 Clip Adapter501010350101032023-12-14
04255629200560SpO2 Adapter, small, 3/BoxSpO2 Adapter, small, 3/Box50100152023-12-14
04255629200577SpO2 Adapter, small, 10/boxSpO2 Adapter, small, 10/box50100242023-12-14
04255629200584SpO2 Adapter, medium, 3/BoxSpO2 Adapter, medium, 3/Box50100142023-12-14
04255629200591SpO2 Adapter, medium, 10/boxSpO2 Adapter, medium, 10/box50100232023-12-14
04255629200607SpO2 Adapter, large, 3/BoxSpO2 Adapter, large, 3/Box50100132023-12-14
04255629200614SpO2 Adapter, large, 10/boxSpO2 Adapter, large, 10/box50100222023-12-14
04255629200355SpO2 Finger Adapter M-Flex501004950100492023-12-14
04255629200379SpO2 Clip Adapter501010350101032023-12-14
04255629200874SpO2 Adapter, small, 10/boxSpO2 Adapter, small, 10/box50100242023-12-14
04255629200881SpO2 Adapter, medium, 10/boxSpO2 Adapter, medium, 10/box50100232023-12-14

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
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