IRADIMED CORP.

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Device Class
Product Code
Premarket Exempt
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- Catalog Number : 1128

Device Description : AC POWER CORD, HOSPITAL GRADE, 10.0 FT.

Device Class : 2

Duns Number: 170301969

Premarket Exempt : No

Product Code : FRN

Prescription Use : Yes

Device Count : 1

- Catalog Number : 1133

Device Description : MRI COMPATIBLE BATTERY PACK

Device Class : 2

Duns Number: 170301969

Premarket Exempt : No

Product Code : FRN

Prescription Use : Yes

Device Count : 1

- Catalog Number : 1145

Device Description : MRIDIUM 3860 DERS LIBRARY KIT

Device Class : 2

Duns Number: 170301969

Premarket Exempt : No

Product Code : FRN

Prescription Use : Yes

Device Count : 1

- Catalog Number : 1170

Device Description : FIBER OPTIC SpO2 CABLE KIT

Device Class : 2

Duns Number: 170301969

Premarket Exempt : No

Product Code : FRN

Prescription Use : Yes

Device Count : 1

- Catalog Number : 3880

Device Description : 3880 MRI Patient Monitoring System

Device Class : 2

Duns Number: 170301969

Premarket Exempt : No

Product Code : MWI

Prescription Use : Yes

Device Count : 1

- Catalog Number : 3881

Device Description : ePOD, 5 Lead ECG Module

Device Class : 2

Duns Number: 170301969

Premarket Exempt : No

Product Code : MWI

Prescription Use : Yes

Device Count : 1

- Catalog Number : 3882

Device Description : oPOD, Spo2 Module

Device Class : 2

Duns Number: 170301969

Premarket Exempt : No

Product Code : MWI

Prescription Use : Yes

Device Count : 1

- Catalog Number : 3885T

Device Description : MRI Monitor Remote Tablet

Device Class : 2

Duns Number: 170301969

Premarket Exempt : No

Product Code : MWI

Prescription Use : Yes

Device Count : 1

- Catalog Number : 3885B

Device Description : MRI Monitor Remote Base/Charger

Device Class : 2

Duns Number: 170301969

Premarket Exempt : No

Product Code : MWI

Prescription Use : Yes

Device Count : 1

- Catalog Number : 3886

Device Description : MRI Wireless Multi-Gas Unit w/O2

Device Class : 2

Duns Number: 170301969

Premarket Exempt : No

Product Code : MWI

Prescription Use : Yes

Device Count : 1