ICU MEDICAL, INC.

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

Set, administration, intravascular (FPA) (9) Stopcock, i.V. Set (FMG) (1)

Premarket Exempt

No Yes

Clear

ICU Medical - 00840619023294 Catalog Number : 20120-01

Device Description : Spiros™ Closed Male Luer

Device Class : 2

Duns Number: 118380146

Premarket Exempt : No

Product Code : FPA

Prescription Use : Yes

Device Count : 1

ICU Medical - 00840619023300 Catalog Number : 20121-01

Device Description : 42" (106 cm) Appx 4.8 ml, 15 Drop Admin Set w/Spiros™, Connector, Bag Hanger

Device Class : 2

Duns Number: 118380146

Premarket Exempt : No

Product Code : FPA

Prescription Use : Yes

Device Count : 1

ICU Medical - 00840619023317 Catalog Number : 20122-01

Device Description : 15" Bifuse Add-On Set w/Bag Spike, Spiros™ w/Red Cap, Vented Cap

Device Class : 2

Duns Number: 118380146

Premarket Exempt : No

Product Code : FPA

Prescription Use : Yes

Device Count : 1

ICU Medical - 00840619023324 Catalog Number : 20123-01

Device Description : 5" Bag Spike Adapter w/Spiros™, Vented Cap

Device Class : 2

Duns Number: 118380146

Premarket Exempt : No

Product Code : FPA

Prescription Use : Yes

Device Count : 1

ICU Medical - 00840619023331 Catalog Number : 20124-01

Device Description : 30" (76 cm) Appx 3.2 ml, 20 Drop Admin Set w/Integrated Clave™ Drip Chamber, Spi 30" (76 cm) Appx 3.2 ml, 20 Drop Admin Set w/Integrated Clave™ Drip Chamber, Spiros™, Bag Hanger

Device Class : 2

Duns Number: 118380146

Premarket Exempt : No

Product Code : FPA

Prescription Use : Yes

Device Count : 1

ICU Medical - 00840619023348 Catalog Number : 20125-01

Device Description : ChemoClave™ Vented Vial Spike

Device Class : 2

Duns Number: 118380146

Premarket Exempt : No

Product Code : FPA

Prescription Use : Yes

Device Count : 1

ICU Medical - 00840619023355 Catalog Number : 20126-01

Device Description : ChemoClave™ Bag Spike with Additive Port

Device Class : 2

Duns Number: 118380146

Premarket Exempt : No

Product Code : FPA

Prescription Use : Yes

Device Count : 1

ICU Medical - 00840619023362 Catalog Number : 20127-01

Device Description : 41" (104 cm ) Appx 4.9 mL, 20 Drop Admin Set w/In-Line Drip Chamber, Filter, Spi 41" (104 cm ) Appx 4.9 mL, 20 Drop Admin Set w/In-Line Drip Chamber, Filter, Spiros™, Hanger, Rotating Luer

Device Class : 2

Duns Number: 118380146

Premarket Exempt : No

Product Code : FPA

Prescription Use : Yes

Device Count : 1

ICU Medical - 00840619023379 Catalog Number : 20129-01

Device Description : Sterile Cap (5 Pack)

Device Class : 2

Duns Number: 118380146

Premarket Exempt : No

Product Code : FMG

Prescription Use : Yes

Device Count : 1

ICU Medical - 00840619023386 Catalog Number : 20130-01

Device Description : Spinning Spiros™ Closed Male Luer, Red Cap

Device Class : 2

Duns Number: 118380146

Premarket Exempt : No

Product Code : FPA

Prescription Use : Yes

Device Count : 1

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