FDA.reportPublic FDA data

Mechanomyography Sensor (MMG) for Neuromuscular Transmission Monitor TOF3D

Primary DI
04255629200751
Brand
Mechanomyography Sensor (MMG) for Neuromuscular Transmission Monitor TOF3D
Company
MIPM Mammendorfer Institut für Physik und Medizin GmbH
Model
5750126
Catalog number
5750126
Published
2025-11-21
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
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
K250887000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K250887000Neuromuscular Transmission Monitor TOF3D (2510091)MIPM Mammendorfer Institut für Physik und Medizin GmbH2025-10-21KOI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04255629200751PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04255629200751042556292007514255629200751

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.

Regulatory Flags#

DUNS number
324416379
Device count
1
Serial number
true
Manufacturing date on label
true

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