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) (9) Electrode, Electrocardiograph (DRX) (1)

Premarket Exempt

No Yes

Clear

Iradimed - 00856038001560 Catalog Number : 1842I-25

Device Description : Cannula, Infant, Neonatal

Device Class : 2

Duns Number: 170301969

Premarket Exempt : No

Product Code : MWI

Prescription Use : Yes

Device Count : 1

Iradimed - 00856038001577 Catalog Number : 1842P-25

Device Description : Cannula, Pediatric

Device Class : 2

Duns Number: 170301969

Premarket Exempt : No

Product Code : MWI

Prescription Use : Yes

Device Count : 1

Iradimed - 00856038001584 Catalog Number : 1843A-25

Device Description : Cannula, Oral, Adult

Device Class : 2

Duns Number: 170301969

Premarket Exempt : No

Product Code : MWI

Prescription Use : Yes

Device Count : 1

Iradimed - 00856038001591 Catalog Number : 1843P-25

Device Description : Cannula, Oral/Nasal Pediatric

Device Class : 2

Duns Number: 170301969

Premarket Exempt : No

Product Code : MWI

Prescription Use : Yes

Device Count : 1

Iradimed - 00856038001607 Catalog Number : 1844A-25

Device Description : Cannula, Adult, Bifurcated

Device Class : 2

Duns Number: 170301969

Premarket Exempt : No

Product Code : MWI

Prescription Use : Yes

Device Count : 1

Iradimed - 00856038001614 Catalog Number : 1844P-25

Device Description : Cannula, Pediatric, Bifurcated

Device Class : 2

Duns Number: 170301969

Premarket Exempt : No

Product Code : MWI

Prescription Use : Yes

Device Count : 1

Iradimed - 00856038001621 Catalog Number : 1891

Device Description : Pole Mount, Rotating, 3880 Monitor

Device Class : 2

Duns Number: 170301969

Premarket Exempt : No

Product Code : MWI

Prescription Use : Yes

Device Count : 1

Iradimed - 00856038001638 Catalog Number : 1831

Device Description : Hose Assembly, NIBP Swift Connect

Device Class : 2

Duns Number: 170301969

Premarket Exempt : No

Product Code : MWI

Prescription Use : Yes

Device Count : 1

Iradimed - 00856038001645 Catalog Number : 1882-3

Device Description : Printer Paper

Device Class : 2

Duns Number: 170301969

Premarket Exempt : No

Product Code : MWI

Prescription Use : Yes

Device Count : 1

Iradimed - 00856038001652 Catalog Number : 1812-25

Device Description : ECG disposable electrode (5 lead)

Device Class : 2

Duns Number: 170301969

Premarket Exempt : Yes

Product Code : DRX

Prescription Use : Yes

Device Count : 1

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