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) Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms) (MWI) (4) Pump, Infusion (FRN) (1) Stand, Infusion (FOX) (1)

Premarket Exempt

Yes No

Clear

Iradimed - 00856038001669 Catalog Number : 1883

Device Description : Mount, Arm, 3886 Agents Module

Device Class : 2

Duns Number: 170301969

Premarket Exempt : No

Product Code : MWI

Prescription Use : Yes

Device Count : 1

Iradimed - 00856038001676 Catalog Number : 1884

Device Description : Mount, Arm, 3880 Monitor

Device Class : 2

Duns Number: 170301969

Premarket Exempt : No

Product Code : MWI

Prescription Use : Yes

Device Count : 1

Iradimed - 00856038001683 Catalog Number : 1171

Device Description : SpO2 Grip Sensor Starter Pack

Device Class : 2

Duns Number: 170301969

Premarket Exempt : No

Product Code : MWI, FRN

Prescription Use : Yes

Device Count : 1

Iradimed - 00856038001690 Catalog Number : 1846-25

Device Description : Scavenge Hose

Device Class : 2

Duns Number: 170301969

Premarket Exempt : No

Product Code : MWI

Prescription Use : Yes

Device Count : 1

Iradimed - 00856038001706 Catalog Number : 1845-25

Device Description : Adaptor, Anesthesia Airway

Device Class : 2

Duns Number: 170301969

Premarket Exempt : No

Product Code : MWI

Prescription Use : Yes

Device Count : 1

Iradimed - 00856038001713 Catalog Number : 1119M

Device Description : ROLL STAND, NON-MAGNETIC, 3880 MONITOR

Device Class : 1

Duns Number: 170301969

Premarket Exempt : Yes

Product Code : FOX

Prescription Use : Yes

Device Count : 1

Iradimed - 00856038001744 Catalog Number : 3883

Device Description : ipPOD, INVASIVE PRESSURE UNIVERSAL, 3880

Device Class : 2

Duns Number: 170301969

Premarket Exempt : No

Product Code : MWI

Prescription Use : Yes

Device Count : 1

Iradimed - 00856038001751 Catalog Number : 1888

Device Description : POD CHARGER, BATTERY BAY 3885B

Device Class : 2

Duns Number: 170301969

Premarket Exempt : No

Product Code : MWI

Prescription Use : Yes

Device Count : 1

Iradimed - 00856038001775 Catalog Number : 1832A-LONG

Device Description : Cuff, NIBP, Adult Long Reuseable (27-35 cm)

Device Class : 2

Duns Number: 170301969

Premarket Exempt : No

Product Code : MWI

Prescription Use : Yes

Device Count : 1

Iradimed - 00856038001782 Catalog Number : 1861

Device Description : CABLE, DUAL IBP UNIVERSAL, REPLACEMENT

Device Class : 2

Duns Number: 170301969

Premarket Exempt : No

Product Code : MWI

Prescription Use : Yes

Device Count : 1

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