FDA.reportPublic FDA data

SpO2 Clip Adapter

Primary DI
04255629200386
Brand
SpO2 Clip Adapter
Company
MIPM Mammendorfer Institut für Physik und Medizin GmbH
Model
5010103
Catalog number
5010103
Published
2023-12-14
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
K142032000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K142032000MRI PATIENT MONITORING SYSTEM TESLA M3Mipm Mammendorfer Institut Fur Physik Und Medizin2015-05-07MWI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04255629200379Direct MarkingGS10
EMIP50101031PreviousHIBCC0
04255629200386PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04255629200379042556292003794255629200379
04255629200386042556292003864255629200386

GMDN Terms#

Term, Definition table
TermDefinition
Pulse oximeter probe, reusableA photoelectric device designed to be applied externally to a body site (e.g., fingertip, ear lobe, bridge of nose, toe, or bridge of the foot) for the transcutaneous measurement of haemoglobin oxygen saturation (SpO2) in arterial blood using signals produced by a light-emitting diode (LED) and received by a photodetector. The signals are subsequently transmitted to an oximeter/monitor (not included) which measures and displays the SpO2. This is a reusable device.

Contacts#

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

Regulatory Flags#

DUNS number
324416379
Device count
2
Lot or batch
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
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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