Carefusion Finland 320 Oy

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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

Cable, Transducer And Electrode, Patient, (Including Connector) (DSA) (5) ANALYZER, GAS, CARBON-DIOXIDE, GASEOUS-PHASE (CCK) (3) ANALYZER, GAS, OXYGEN, GASEOUS-PHASE (CCL) (1) ELECTRODE, CIRCULAR (SPIRAL), SCALP AND APPLICATOR (HGP) (1)

Premarket Exempt

No Yes

Clear

Vital Signs™ - 10190752103726 Catalog Number : 2089797-001

Device Description : Vital Signs™ Leadwire Set, Diagnostic Cardiology Universal-ended Mixed 14/set AHA

Device Class : 2

Duns Number: 367919120

Premarket Exempt : No

Product Code : DSA

Prescription Use : Yes

Device Count : 1

Vital Signs™ - 10190752103733 Catalog Number : 2089797-002

Device Description : Vital Signs™ Leadwire Set, Diagnostic Cardiology Universal-ended Mixed 10/set AHA

Device Class : 2

Duns Number: 367919120

Premarket Exempt : No

Product Code : DSA

Prescription Use : Yes

Device Count : 1

Vital Signs™ - 10190752103764 Catalog Number : 2089799-001

Device Description : Vital Signs™ Leadwire, Diagnostic Cardiology, Universal-ended V3R, AHA, 66cm/ 26in

Device Class : 2

Duns Number: 367919120

Premarket Exempt : No

Product Code : DSA

Prescription Use : Yes

Device Count : 1

Vital Signs™ - 10190752103771 Catalog Number : 2089799-002

Device Description : Vital Signs™ Leadwire, Diagnostic Cardiology, Universal-ended V4R, AHA, 66cm/ 26in

Device Class : 2

Duns Number: 367919120

Premarket Exempt : No

Product Code : DSA

Prescription Use : Yes

Device Count : 1

Vital Signs™ - 10190752103788 Catalog Number : 2089799-003

Device Description : Vital Signs™ Leadwire, Diagnostic Cardiology, Universal-ended V7, AHA, 66cm/ 26in

Device Class : 2

Duns Number: 367919120

Premarket Exempt : No

Product Code : DSA

Prescription Use : Yes

Device Count : 1

Vital Signs - 10885403248931 Catalog Number : 402667-001

Device Description : CO2 B-Line and Elbow Adapter, Disposable

Device Class : 2

Duns Number: 367919120

Premarket Exempt : No

Product Code : CCK

Prescription Use : Yes

Device Count : 1

Vital Signs - 10885403248948 Catalog Number : 402667-002

Device Description : CO2 B-Line and Straight Adapter, Disposable

Device Class : 2

Duns Number: 367919120

Premarket Exempt : No

Product Code : CCK

Prescription Use : Yes

Device Count : 1

Vital Signs - 10885403248955 Catalog Number : 402667-003

Device Description : CO2 B-Line, Disposable

Device Class : 2

Duns Number: 367919120

Premarket Exempt : No

Product Code : CCK

Prescription Use : Yes

Device Count : 1

Vital Signs - 10885403248962 Catalog Number : 7000AAO

Device Description : Fetal Spiral Electrode For Corometrics

Device Class : 2

Duns Number: 367919120

Premarket Exempt : No

Product Code : HGP

Prescription Use : Yes

Device Count : 1

Vital Signs - 10885403248986 Catalog Number : 73318-HEL

Device Description : Anesthesia Gas Sampling Line, Disposable 2 m/7 ft

Device Class : 2

Duns Number: 367919120

Premarket Exempt : No

Product Code : CCL

Prescription Use : Yes

Device Count : 1

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