ICU MEDICAL, INC.

Address:13520 EVENING CREEK DRIVE NORTH,SAN DIEGO,CA,92128,US

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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

Closed antineoplastic and hazardous drug reconstitution and transfer system (ONB) (4) Set, administration, intravascular (FPA) (4) Stopcock, i.V. Set (FMG) (2)

Premarket Exempt

No Yes

Clear

ICU Medical - 00840619023881 Catalog Number :

Device Description : 16" Trifuse Add-On Set w/2 Clave® Spike, Vented Cap

Device Class : 2

Duns Number: 118380146

Premarket Exempt : No

Product Code : FMG

Prescription Use : No

Device Count : 1

ICU Medical - 00840619023928 Catalog Number : CH3007

Device Description : 75" (191 cm) Appx 9.0 ml, 20 Drop Admin Set w/Integrated Clave™ Drip Chamber, Spiros™

Device Class : 2

Duns Number: 118380146

Premarket Exempt : No

Product Code : FPA

Prescription Use : Yes

Device Count : 1

ICU Medical - 00840619023966 Catalog Number : CH3011

Device Description : 30" (76 cm) Appx 3.3 mL, Admin Set w/20 Drop Integrated Clave™ Drip Chamber, Spi 30" (76 cm) Appx 3.3 mL, Admin Set w/20 Drop Integrated Clave™ Drip Chamber, Spiros™, Hanger

Device Class : 2

Duns Number: 118380146

Premarket Exempt : No

Product Code : ONB

Prescription Use : Yes

Device Count : 1

ICU Medical - 00840619024000 Catalog Number : CH3020

Device Description : 40" Admin Set w/2 Spiros™, 20 Drop In-Line Drip Chamber, Hanger

Device Class : 2

Duns Number: 118380146

Premarket Exempt : No

Product Code : ONB

Prescription Use : Yes

Device Count : 1

ICU Medical - 00840619024017 Catalog Number : CH3022

Device Description : 36" 10 Drop Admin Set w/Rotating Luer

Device Class : 2

Duns Number: 118380146

Premarket Exempt : No

Product Code : FMG

Prescription Use : Yes

Device Count : 1

ICU Medical - 00840619024024 Catalog Number :

Device Description : 41" (104 cm) Appx 4.8 mL, 15 Drop Admin Set w/Spiros®, Bag Hanger

Device Class : 2

Duns Number: 118380146

Premarket Exempt : No

Product Code : FPA

Prescription Use : No

Device Count : 1

ICU Medical - 00840619024055 Catalog Number :

Device Description : 14" Bifuse Add-On Set w/Bag Spike, Spiros®, Vented Cap

Device Class : 2

Duns Number: 118380146

Premarket Exempt : No

Product Code : FPA

Prescription Use : No

Device Count : 1

ICU Medical - 00840619024062 Catalog Number : CH3029

Device Description : 40" (102 cm) Appx 4.8 ml, 20 Drop Admin Set w/In-Line Drip Chamber, Spiros™, Han 40" (102 cm) Appx 4.8 ml, 20 Drop Admin Set w/In-Line Drip Chamber, Spiros™, Hanger, Rotating Luer

Device Class : 2

Duns Number: 118380146

Premarket Exempt : No

Product Code : FPA

Prescription Use : Yes

Device Count : 1

ICU Medical - 00840619024109 Catalog Number :

Device Description : 14" Bifuse Add-On Set w/Bag Spike, Spiros® w/Red Cap, Vented Cap

Device Class : 2

Duns Number: 118380146

Premarket Exempt : No

Product Code : ONB

Prescription Use : No

Device Count : 1

ICU Medical - 00840619024116 Catalog Number :

Device Description : 5" (13 cm) Bag Spike Adapter w/Spiros™ w/Red Cap, Vented Cap

Device Class : 2

Duns Number: 118380146

Premarket Exempt : No

Product Code : ONB

Prescription Use : No

Device Count : 1

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