FDA.reportPublic FDA data

Trolley TeslaDUO including MFI

Primary DI
04255629200522
Brand
Trolley TeslaDUO including MFI
Company
MIPM Mammendorfer Institut für Physik und Medizin GmbH
Model
Trolley TeslaDUO including MFI
Catalog number
6300040
Published
2024-01-25
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
MWIMonitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MWIMonitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)Cardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K153739000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K153739000MRI Patient Monitor TeslaDUOMipm Mammendorfer Institut Fur Physik Und Medizin2016-06-28MWI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
EMIP63000400PreviousHIBCC0
04255629200522PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04255629200522042556292005224255629200522

GMDN Terms#

Term, Definition table
TermDefinition
Electromechanical device/system transport trolleyA mobile (on wheels) cart intended to be used as a carrier for transporting an electromechanical device(s) or a powered system assembly. This trolley (cart) may be designed specifically for a proprietary control unit/system, and will typically have one or more horizontal surfaces where the devices are placed; it may include additional features (e.g., gas cylinder holder, intravenous pole) specific to a proprietary system. Neither electromechanical devices nor system components are included.

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
324416379
Device count
1
Serial number
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
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
04255629200898SpO2 Adapter, large, 10/boxSpO2 Adapter, large, 10/box50100222023-12-14

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Primary DI, Brand, Company table
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00850086928022SENSINEL™ CARDIOPULMONARY MANAGEMENT (CPM) SYSTEM)Analog Devices, Inc.MWI2026-06-03
00850086928039SENSINEL™ CARDIOPULMONARY MANAGEMENT (CPM) SYSTEM)Analog Devices, Inc.MWI2026-06-03
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B3945700048070WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.MWI2026-05-27
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B3945700048100WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.MWI2026-05-27
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08719689142179QMAPP Fysicon B.V.MWI2026-05-19
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