FDA.reportPublic FDA data

Iradimed

Primary DI
00856038001195
Brand
Iradimed
Company
IRADIMED CORP.
Model
3882
Catalog number
3882
Device description
oPOD, Spo2 Module
Published
2017-11-17
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
true

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
K172200000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K1722000003880 MRI Patient Monitoring SystemIradimed Corporation2017-10-25MWI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00856038001195PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00856038001195008560380011958560380011950856038001195

GMDN Terms#

Term, Definition table
TermDefinition
Patient monitoring system module, pulse oximetryA small unit dedicated to the transcutaneous measurement of haemoglobin oxygen saturation (SpO2) in blood using light detection methods (spectrophotometry) after light is emitted from a light-emitting diode (LED) situated in the connected probe. It is designed to operate as part of a patient monitoring system enhancing the function of this system (the parent device). The module automatically plugs into the parent device when the user places it into a standardized slot in the parent device or a connected module rack. The parent device operates as a mainframe computer displaying the pulse oximetry parameters provided by this module.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
170301969
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00856038001553Iradimed1842A-251842A-252017-11-17
00856038001560Iradimed1842I-251842I-252017-11-17
00856038001577Iradimed1842P-251842P-252017-11-17
00856038001584Iradimed1843A-251843A-252017-11-17
00856038001607Iradimed1844A-251844A-252017-11-17
00856038001621Iradimed189118912017-11-17
00856038001669Iradimed188318832017-11-17
00856038001676Iradimed188418842017-11-17
00856038001348Iradimed181118112017-11-17
00856038001713Iradimed1119M1119M2020-08-20
00856038001065Iradimed111911192016-08-25
00856038001140Iradimed113311332016-08-25
00856038001232Iradimed118811882017-11-17
00856038001706Iradimed1845-251845-252017-12-07
00856038001072Iradimed386138612016-08-25
00856038001447Iradimed1841-251841-252017-11-17
00856038001690Iradimed1846-251846-252017-11-17
00856038001089Iradimed3860+3860+2016-08-25
00856038001362Iradimed3883-13883-12022-06-20
00856038001379Iradimed3883-23883-22022-06-20

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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17540262170054Change Healthcare Cardiology HemodynamicsChange Healthcare Canada CompanyMWI2026-07-21
03615041990578Capsule SurveillancePhilips North America LLCMWI2026-07-14
08684906452600Arc SystemM2AN DIGITAL HEALTH INC.MWI2026-06-29
04255629200966NIBP Pressure cuff 9 - 15 cmMIPM Mammendorfer Institut für Physik und Medizin GmbHMWI2026-06-24
04255629200973NIBP Pressure cuff 14 - 21,5 cmMIPM Mammendorfer Institut für Physik und Medizin GmbHMWI2026-06-24
04255629200980NIBP Pressure cuff 20,5 - 28,5 cmMIPM Mammendorfer Institut für Physik und Medizin GmbHMWI2026-06-24
04255629200997NIBP Pressure cuff 27 - 35 cmMIPM Mammendorfer Institut für Physik und Medizin GmbHMWI2026-06-24
04255629201000NIBP Pressure cuff 34 - 44 cmMIPM Mammendorfer Institut für Physik und Medizin GmbHMWI2026-06-24
04255629201017Gas Sample Line SetMIPM Mammendorfer Institut für Physik und Medizin GmbHMWI2026-06-24
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00850086928015SENSINEL™ CPM WEARABLEAnalog Devices, Inc.MWI2026-06-03
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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