ICU MEDICAL, INC.

Address:600 N Field Dr,Lake Forest,IL,60045,US

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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

Set, administration, intravascular (FPA) (6) Stopcock, i.V. Set (FMG) (3) Closed antineoplastic and hazardous drug reconstitution and transfer system (ONB) (1)

Premarket Exempt

No Yes

Clear

ICU Medical - 00840619024123 Catalog Number : CH3035

Device Description : 75" (191 cm) Appx 9.1 ml, 20 Drop Admin Set w/ Integrated Clave™ Drip Chamber, C 75" (191 cm) Appx 9.1 ml, 20 Drop Admin Set w/ Integrated Clave™ Drip Chamber, Clave™, Spiros™

Device Class : 2

Duns Number: 118380146

Premarket Exempt : No

Product Code : FPA

Prescription Use : Yes

Device Count : 1

ICU Medical - 00840619024307 Catalog Number :

Device Description : 7" Ext Set w/MicroClave®, Clave®, Clamp, Rotating Luer

Device Class : 2

Duns Number: 118380146

Premarket Exempt : No

Product Code : FMG

Prescription Use : No

Device Count : 1

ICU Medical - 00840619024345 Catalog Number : CH3067

Device Description : 16" (41 cm) Appx 4.5 mL, Bifuse Add-On Set, w/Clave™ Spike, Bag Spike, 2 Clamps 16" (41 cm) Appx 4.5 mL, Bifuse Add-On Set, w/Clave™ Spike, Bag Spike, 2 Clamps (Red, Blue), Dry Spike Adapter

Device Class : 2

Duns Number: 118380146

Premarket Exempt : No

Product Code : FMG

Prescription Use : Yes

Device Count : 1

ICU Medical - 00840619024451 Catalog Number : CH3083

Device Description : 15" (38 cm) Appx 7.7 ml, Quadfuse Add-On Set w/4 Bag Spikes ,Vented Cap

Device Class : 2

Duns Number: 118380146

Premarket Exempt : No

Product Code : FMG

Prescription Use : Yes

Device Count : 1

ICU Medical - 00840619024628 Catalog Number : CH3110

Device Description : 5" Smallbore Ext Set w/Spiros™

Device Class : 2

Duns Number: 118380146

Premarket Exempt : No

Product Code : FPA

Prescription Use : Yes

Device Count : 1

ICU Medical - 00840619024802 Catalog Number : CH3128

Device Description : 30" (76 cm) Appx 5.9 ml, 20 Drop Admin Set w/Integrated ChemoClave™ Drip Chamber 30" (76 cm) Appx 5.9 ml, 20 Drop Admin Set w/Integrated ChemoClave™ Drip Chamber, 0.2 Micron Filter, Spiros™ w/Red Cap, Hanger

Device Class : 2

Duns Number: 118380146

Premarket Exempt : No

Product Code : ONB

Prescription Use : Yes

Device Count : 1

ICU Medical - 00840619024871 Catalog Number : CH3135

Device Description : 40" (102 cm) Appx 4.5 ml, 20 Drop Admin Set w/Integrated Clave™ Drip Chamber, Sp 40" (102 cm) Appx 4.5 ml, 20 Drop Admin Set w/Integrated Clave™ Drip Chamber, Spiros™, Hanger

Device Class :

Duns Number: 118380146

Premarket Exempt : No

Product Code : FPA

Prescription Use : Yes

Device Count : 1

ICU Medical - 00840619025076 Catalog Number : CH3156

Device Description : 14" (36 cm) Appx 4.8 ml, Bifuse Add-On Set w/Spiros™ w/Red Cap, Bag Spike, 3 Cla 14" (36 cm) Appx 4.8 ml, Bifuse Add-On Set w/Spiros™ w/Red Cap, Bag Spike, 3 Clamps (Blue, 2 White), Vented Cap, Drop-In Spiros™ w/Red Cap

Device Class : 2

Duns Number: 118380146

Premarket Exempt : No

Product Code : FPA

Prescription Use : Yes

Device Count : 1

ICU Medical - 00840619025090 Catalog Number :

Device Description : 96" (244 cm) Appx 11.8 ml, 15 Drop Admin Set, Clave®, Rotating Luer

Device Class : 2

Duns Number: 118380146

Premarket Exempt : No

Product Code : FPA

Prescription Use : No

Device Count : 1

ICU Medical - 00840619025236 Catalog Number : CH3176

Device Description : 8" Ext Set w/Spiros™, Plug Adapter

Device Class : 2

Duns Number: 118380146

Premarket Exempt : No

Product Code : FPA

Prescription Use : Yes

Device Count : 1

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