FDA.reportPublic FDA data

Iradimed

Primary DI
00856038001096
Brand
Iradimed
Company
IRADIMED CORP.
Model
3865
Catalog number
3865
Device description
MRIDIUM 3865 REMOTE MONITOR
Published
2016-08-25
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true

Product Codes#

Code, Name table
CodeName
LDRController, Infusion, Intravascular, Electronic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LDRController, Infusion, Intravascular, ElectronicGeneral Hospital2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K090087000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K090087000MRIDIUM 3860 MRI INFUSION PUMP/MONITORING SYSTEMIradimed Corporation2009-04-07FRN

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00856038001096PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00856038001096008560380010968560380010960856038001096

GMDN Terms#

Term, Definition table
TermDefinition
Infusion pump 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 an infusion pump (e.g., analgesia infusion pump, insulin infusion pump) 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

Regulatory Flags#

DUNS number
170301969
Device count
1
Serial number
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
08436020769153DOSI-FLOWLEVENTON SAULDR2023-09-08
08436020769160DOSI-FLOWLEVENTON SAULDR2023-09-08
18436020769150DOSI-FLOWLEVENTON SAULDR2023-09-08
18436020769167DOSI-FLOWLEVENTON SAULDR2023-09-08
08436020760099DOSI-FLOWLEVENTON SAULDR2016-11-30
08436020760914DOSI-FLOWLEVENTON SAULDR2016-11-30
18436020760096DOSI-FLOWLEVENTON SAULDR2016-11-30
18436020760911DOSI-FLOWLEVENTON SAULDR2016-11-30