FDA.reportPublic FDA data

Iradimed

Primary DI
00856038001942
Brand
Iradimed
Company
IRADIMED CORP.
Model
3870
Published
2026-10-08
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
false
OTC
false
Sterile
false
Single use
false

Product Codes#

Code, Name table
CodeName
FRNPump, Infusion

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FRNPump, InfusionGeneral Hospital2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K242752000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K242752000MRidium 3870 MRI Infusion Pump System (3870)Iradimed Corporation2025-05-28FRN

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00856038001942PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00856038001942008560380019428560380019420856038001942

GMDN Terms#

Term, Definition table
TermDefinition
Bedside infusion pump, single-channelAn electrically-powered, non-ambulatory (bedside) device designed to facilitate the accurate and consistent administration of a single drug/solution which can be delivered via intravenous, subcutaneous, arterial, epidural, and intracavital routes using a dedicated infusion set; it is not dedicated to a specific treatment type. It is used to supply higher pressures than those provided by gravity infusion sets or infusion controllers (e.g., typical flow range of 1 to 999 ml/hour) and delivers solutions from a standard infusion bag or bottle of fluid. It is intended primarily for use at the bedside but typically has internal batteries that enable operation, e.g., during transportation.

Regulatory Flags#

DUNS number
170301969
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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
10885403519437BD Alaris™ PCU Module, Model 8015CAREFUSION 303, INC.FRN2026-10-08
10885403533211BD Alaris™ PCU Model 8015CAREFUSION 303, INC.FRN2026-10-08
10885403533273BD Alaris™ Syringe Module Model 8110CAREFUSION 303, INC.FRN2026-10-08
10885403533297BD Alaris™ PCU Model 8015CAREFUSION 303, INC.FRN2026-10-08
10885403533334BD Alaris™ Syringe Module Model 8110CAREFUSION 303, INC.FRN2026-10-08
10885403533426BD Alaris™ Pump Module, Model 8100CAREFUSION 303, INC.FRN2026-10-08
10885403535215BD Alaris™ Pump Module, Model 8100CAREFUSION 303, INC.FRN2026-10-08
10885403542930BD Alaris™ Pump Module, Model 8100CAREFUSION 303, INC.FRN2026-10-08
05060844770014SAFIRAMEDOVATE LIMITEDFRN2026-10-05
05060844770021SAFIRAMEDOVATE LIMITEDFRN2026-10-05
05060844770038SAFIRAMEDOVATE LIMITEDFRN2026-10-05
05060844770045SAFIRAMEDOVATE LIMITEDFRN2026-10-05
05060844770052SAFIRAMEDOVATE LIMITEDFRN2026-10-05
04046955664214B.BRAUNB. BRAUN MEDICAL INC.FRN2026-07-12
04046961034704Perfusor®B. BRAUN MEDICAL INC.FRN2026-06-25
04046961034834Perfusor®B. BRAUN MEDICAL INC.FRN2026-06-25
08500835120017Avoset Optum Homecare InfusionOptum Distribution Center, LLCFRN2026-02-24
17290109155309Sapphire M.T. Pump Kit CEITAN MEDICAL LTDFRN2024-09-04
30815112021345Elution Test Vial Bracco Diagnostics Inc.FRN2024-02-13
10815112021396CardioGen-82 Infusion System Model 1700Bracco Diagnostics Inc.FRN2023-12-01
10815112021358CardioGen Patient Administration SetBracco Diagnostics Inc.FRN2023-10-16
17290109155149Sapphire Epidural Infusion Kit - US EITAN MEDICAL LTDFRN2023-09-05
30815112021338Accessory PackageBracco Diagnostics Inc.FRN2023-06-29
30815112020034Accessory PackageBracco Diagnostics Inc.FRN2023-03-22
30815112020614Accessory PackageBracco Diagnostics Inc.FRN2023-03-22
17290109154272Sapphire Epidural Infusion Pump Kit – USEITAN MEDICAL LTDFRN2022-05-15
17290109154289Sapphire M.T Infusion Pump Kit- US - S kit EITAN MEDICAL LTDFRN2022-05-15
17290109154265Sapphire M.T Infusion Pump Kit – USEITAN MEDICAL LTDFRN2022-05-11
10814844000365Curlin IV Pump SystemZEVEX INTERNATIONAL, INC.FRN2021-04-29
15019517177367PharmGuardICU MEDICAL, INC.FRN2020-03-20