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) (10)

Premarket Exempt

No Yes

Clear

Iradimed - 00856038001461 Catalog Number : 1832A

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

Device Class : 2

Duns Number: 170301969

Premarket Exempt : No

Product Code : MWI

Prescription Use : Yes

Device Count : 1

Iradimed - 00856038001478 Catalog Number : 1832SA

Device Description : Cuff, NIBP, Small Adult Reusable (20.5-28.5 cm)

Device Class : 2

Duns Number: 170301969

Premarket Exempt : No

Product Code : MWI

Prescription Use : Yes

Device Count : 1

Iradimed - 00856038001485 Catalog Number : 1832P

Device Description : Cuff, NIBP, Pediatric Reusable (14-21.5 cm)

Device Class : 2

Duns Number: 170301969

Premarket Exempt : No

Product Code : MWI

Prescription Use : Yes

Device Count : 1

Iradimed - 00856038001492 Catalog Number : 1832I

Device Description : Cuff, NIBP, Infant Reusable (9-15 cm)

Device Class : 2

Duns Number: 170301969

Premarket Exempt : No

Product Code : MWI

Prescription Use : Yes

Device Count : 1

Iradimed - 00856038001508 Catalog Number : 1833N1-10

Device Description : Cuff, NIBP, Neonatal Size 1 (3-6 cm)

Device Class : 2

Duns Number: 170301969

Premarket Exempt : No

Product Code : MWI

Prescription Use : Yes

Device Count : 1

Iradimed - 00856038001515 Catalog Number : 1833N2-10

Device Description : Cuff, NIBP, Neonatal Size 2 (4-8 cm)

Device Class : 2

Duns Number: 170301969

Premarket Exempt : No

Product Code : MWI

Prescription Use : Yes

Device Count : 1

Iradimed - 00856038001522 Catalog Number : 1833N3-10

Device Description : Cuff, NIBP, Neonatal size 3 (6-11 cm)

Device Class : 2

Duns Number: 170301969

Premarket Exempt : No

Product Code : MWI

Prescription Use : Yes

Device Count : 1

Iradimed - 00856038001539 Catalog Number : 1833N4-10

Device Description : Cuff, NIBP, Neonatal Size 4 (7-13 cm)

Device Class : 2

Duns Number: 170301969

Premarket Exempt : No

Product Code : MWI

Prescription Use : Yes

Device Count : 1

Iradimed - 00856038001546 Catalog Number : 1851

Device Description : Temperature Sensor, Fiber Optic

Device Class : 2

Duns Number: 170301969

Premarket Exempt : No

Product Code : MWI

Prescription Use : Yes

Device Count : 1

Iradimed - 00856038001553 Catalog Number : 1842A-25

Device Description : Cannula, Adult

Device Class : 2

Duns Number: 170301969

Premarket Exempt : No

Product Code : MWI

Prescription Use : Yes

Device Count : 1

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