IRADIMED CORP.

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Filters

Device Class

Class-1 (A medical device with low to moderate risk that requires general controls) Class-2 (A medical device with a moderate to high risk that requires special controls) Class-3 (A medical device with high risk that requires premarket approval) Class-U (Unclassified)

Product Code

Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms) (MWI) (5) Pump, Infusion (FRN) (1)

Premarket Exempt

No Yes

Clear

Iradimed - 00856038001799 Catalog Number : 1862

Device Description : CABLE, DUAL IBP TRUWAVE, REPLACEMENT

Device Class : 2

Duns Number: 170301969

Premarket Exempt : No

Product Code : MWI

Prescription Use : Yes

Device Count : 1

Iradimed - 00856038001805 Catalog Number : 1863

Device Description : CABLE, DUAL IBP TRANSPAC IV, REPLACEMENT

Device Class : 2

Duns Number: 170301969

Premarket Exempt : No

Product Code : MWI

Prescription Use : Yes

Device Count : 1

Iradimed - 00856038001812 Catalog Number : 1195

Device Description : HE116 High Gain Antenna

Device Class : 2

Duns Number: 170301969

Premarket Exempt : No

Product Code : MWI

Prescription Use : Yes

Device Count : 1

Iradimed - 00856038001829 Catalog Number : 1190-12

Device Description : Jacket, Disposable, POD

Device Class : 2

Duns Number: 170301969

Premarket Exempt : No

Product Code : MWI

Prescription Use : Yes

Device Count : 1

Iradimed - 00856038001836 Catalog Number : IVP1054

Device Description : Assembly, IV Set, Extension, 92 Inches

Device Class : 2

Duns Number: 170301969

Premarket Exempt : No

Product Code : FRN

Prescription Use : Yes

Device Count : 1

Iradimed - 00856038001874 Catalog Number : 3883-3

Device Description : ipPOD, Invasive Pressure, Transpac, 3880

Device Class : 2

Duns Number: 170301969

Premarket Exempt : No

Product Code : MWI

Prescription Use : Yes

Device Count : 1

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