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

Stopcock, i.V. Set (FMG) (8) Set, administration, intravascular (FPA) (2)

Premarket Exempt

No Yes

Clear

ICU Medical - 00840619000011 Catalog Number : 011-C1000

Device Description : Clave™ Connector

Device Class : 2

Duns Number: 118380146

Premarket Exempt : No

Product Code : FPA

Prescription Use : Yes

Device Count : 1

ICU Medical - 00840619000028 Catalog Number : 011-27071

Device Description : 83" (211 cm) 10.3 mL, 15 Drop Admin Set w/MicroClave™, Rotating Luer

Device Class : 2

Duns Number: 118380146

Premarket Exempt : No

Product Code : FMG

Prescription Use : Yes

Device Count : 1

ICU Medical - 00840619000042 Catalog Number : 011-27080

Device Description : 100" (254 cm) 15 Drop Primary Set w/2 Clave™, Rotating Luer

Device Class : 2

Duns Number: 118380146

Premarket Exempt : No

Product Code : FMG

Prescription Use : Yes

Device Count : 1

ICU Medical - 00840619001421 Catalog Number : 011-C3300

Device Description : MicroClave™ Connector

Device Class : 2

Duns Number: 118380146

Premarket Exempt : No

Product Code : FPA

Prescription Use : Yes

Device Count : 1

ICU Medical - 00840619001537 Catalog Number : 011-C3302

Device Description : 7" (18 cm) Appx 0.24 ml, Smallbore Ext Set w/MicroClave™, Clamp, Rotating Luer

Device Class : 2

Duns Number: 118380146

Premarket Exempt : No

Product Code : FMG

Prescription Use : Yes

Device Count : 1

ICU Medical - 00840619001650 Catalog Number : 011-C3312

Device Description : 8" (20 cm) Appx 1.2 ml, Bifuse Ext Set w/2 MicroClave™, Rotating Luer

Device Class : 2

Duns Number: 118380146

Premarket Exempt : No

Product Code : FMG

Prescription Use : Yes

Device Count : 1

ICU Medical - 00840619001742 Catalog Number : 011-C3322

Device Description : 5" (13 cm) Appx 0.33 ml, Smallbore Bifuse Ext Set w/2 MicroClave™, 2 Clamps, Rotating Luer

Device Class : 2

Duns Number: 118380146

Premarket Exempt : No

Product Code : FMG

Prescription Use : Yes

Device Count : 1

ICU Medical - 00840619001773 Catalog Number : 011-C3323

Device Description : 18 cm (7") Appx 0.56 ml, Smallbore Trifuse Ext Set w/3 MicroClave™, 3 Clamps, Ro 18 cm (7") Appx 0.56 ml, Smallbore Trifuse Ext Set w/3 MicroClave™, 3 Clamps, Rotating Luer

Device Class : 2

Duns Number: 118380146

Premarket Exempt : No

Product Code : FMG

Prescription Use : Yes

Device Count : 1

ICU Medical - 00840619005955 Catalog Number : 011-CS-10

Device Description : Clave™ Connector IV Bag Access Device

Device Class : 2

Duns Number: 118380146

Premarket Exempt : No

Product Code : FMG

Prescription Use : Yes

Device Count : 1

ICU Medical - 00840619006020 Catalog Number : 011-CS-15

Device Description : Clave™ Conn, IV Bag Access Device, BCV

Device Class : 2

Duns Number: 118380146

Premarket Exempt : No

Product Code : FMG

Prescription Use : Yes

Device Count : 1

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