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

Pump, Infusion (FRN) (8) Controller, Infusion, Intravascular, Electronic (LDR) (1) Stand, Infusion (FOX) (1)

Premarket Exempt

No Yes

Clear

Iradimed - 00856038001027 Catalog Number : IVP1056

Device Description : 1056 IV Set, Sterile Disp, W / Drip Chamber

Device Class : 2

Duns Number: 170301969

Premarket Exempt : No

Product Code : FRN

Prescription Use : Yes

Device Count : 1

Iradimed - 00856038001041 Catalog Number : IVP1057

Device Description : 1057 IV SET, SYRINGE ADAPTER, STERILE DISP

Device Class :

Duns Number: 170301969

Premarket Exempt : No

Product Code : FRN

Prescription Use : Yes

Device Count : 1

Iradimed - 00856038001058 Catalog Number : IVP1058

Device Description : 1058 IV SET, STERILE DISP, EXTENSION SET

Device Class : 2

Duns Number: 170301969

Premarket Exempt : No

Product Code : FRN

Prescription Use : Yes

Device Count : 1

Iradimed - 00856038001065 Catalog Number : 1119

Device Description : ROLL STAND, NON-MAGNETIC

Device Class : 1

Duns Number: 170301969

Premarket Exempt : Yes

Product Code : FOX

Prescription Use : Yes

Device Count : 1

Iradimed - 00856038001072 Catalog Number : 3861

Device Description : MRIDIUM 3861 SIDECAR SECOND CHANNEL (INFUSION PUMP)

Device Class : 2

Duns Number: 170301969

Premarket Exempt : No

Product Code : FRN

Prescription Use : Yes

Device Count : 1

Iradimed - 00856038001089 Catalog Number : 3860+

Device Description : MRIDIUM MR INFUSION PUMP W/SP02

Device Class : 2

Duns Number: 170301969

Premarket Exempt : No

Product Code : FRN

Prescription Use : Yes

Device Count : 1

Iradimed - 00856038001096 Catalog Number : 3865

Device Description : MRIDIUM 3865 REMOTE MONITOR

Device Class : 2

Duns Number: 170301969

Premarket Exempt : No

Product Code : LDR

Prescription Use : Yes

Device Count : 1

Iradimed - 00856038001102 Catalog Number : 1120

Device Description : EXTERNAL DC POWER/CHARGER, MR IV PUMP

Device Class : 2

Duns Number: 170301969

Premarket Exempt : No

Product Code : FRN

Prescription Use : Yes

Device Count : 1

Iradimed - 00856038001119 Catalog Number : 1121

Device Description : AC POWER CORD, HOSPITAL GRADE, 3.0 FT.

Device Class : 2

Duns Number: 170301969

Premarket Exempt : No

Product Code : FRN

Prescription Use : Yes

Device Count : 1

Iradimed - 00856038001126 Catalog Number : 1122

Device Description : CABLE, DC CHARGER, 10 FT.

Device Class : 2

Duns Number: 170301969

Premarket Exempt : No

Product Code : FRN

Prescription Use : Yes

Device Count : 1

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