FDA.reportPublic FDA data

TeslaDUO Remote Control

Primary DI
04255629200515
Brand
TeslaDUO Remote Control
Company
MIPM Mammendorfer Institut für Physik und Medizin GmbH
Model
5100047
Catalog number
5100047
Published
2024-01-25
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
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
04255629200515PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04255629200515042556292005154255629200515

GMDN Terms#

Term, Definition table
TermDefinition
Patient monitor remote controlA hand-operated electronic unit with a configuration of analogue or digital push-buttons (alphanumeric, colour-, or symbol-coded) designed to control the functions of a patient monitor from a distance via a connected cable or wirelessly [e.g., radio-frequency (RF), infrared (IR) transmission]. It is intended to be operated by the patient or healthcare provider.

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
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
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
B3944060056010WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.MWI2026-05-27
B3944670047010WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.MWI2026-05-27
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B3945700048020WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.MWI2026-05-27
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B3945700048060WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.MWI2026-05-27
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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