Carefusion Finland 320 Oy

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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

CABLE, TRANSDUCER AND ELECTRODE, PATIENT, (INCLUDING CONNECTOR) (DSA) (3) Thermometer, electronic, clinical (FLL) (3) ANALYZER, GAS, CARBON-DIOXIDE, GASEOUS-PHASE (CCK) (2) Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase (CCK) (1) CATHETER, UPPER URINARY TRACT (EYC) (1)

Premarket Exempt

Yes No

Clear

N/A - 10885403251627 Catalog Number : M1024222

Device Description : Skin Temperature Probe,Disposable

Device Class : 2

Duns Number: 367919120

Premarket Exempt : No

Product Code : FLL

Prescription Use : Yes

Device Count : 1

N/A - 10885403251634 Catalog Number : M1024233

Device Description : Tympanic Temperature Probe with Foam, Disposable

Device Class : 2

Duns Number: 367919120

Premarket Exempt : No

Product Code : FLL

Prescription Use : Yes

Device Count : 1

N/A - 10885403251641 Catalog Number : M1024237

Device Description : Tympanic Temperature Probe without Foam, Disposable

Device Class : 2

Duns Number: 367919120

Premarket Exempt : No

Product Code : FLL

Prescription Use : Yes

Device Count : 1

N/A - 10885403251658 Catalog Number : M1024244

Device Description : Foley Catheter with Temperature Probe, Disposable, 18 Fr

Device Class : 2

Duns Number: 367919120

Premarket Exempt : No

Product Code : EYC

Prescription Use : Yes

Device Count : 1

Vital Signs™ - 10885403251702 Catalog Number : M1145072

Device Description : Vital Signs™ Gas Sampling Line, Multipatient, with Elbow Connector, Disposable, 3m/10ft

Device Class : 2

Duns Number: 367919120

Premarket Exempt : No

Product Code : CCK

Prescription Use : Yes

Device Count : 1

Vital Signs - 10885403251757 Catalog Number : 2001925-006

Device Description : Diagnostic Cardiology Universal Leadwire, Individual, 90 cm/36 in

Device Class : 2

Duns Number: 367919120

Premarket Exempt : No

Product Code : DSA

Prescription Use : Yes

Device Count : 1

Vital Signs - 10885403251900 Catalog Number : 2013068-001

Device Description : Adult /Pediatric Airway Adapter for CapnoFlex Module

Device Class : 2

Duns Number: 367919120

Premarket Exempt : No

Product Code : CCK

Prescription Use : Yes

Device Count : 1

Vital Signs - 10885403251917 Catalog Number : 2013069-001

Device Description : Sampling Line with Male Luer for CapnoFlex Module

Device Class : 2

Duns Number: 367919120

Premarket Exempt : No

Product Code : CCK

Prescription Use : Yes

Device Count : 1

Multi-Link - 10885403252051 Catalog Number : 2052104-005

Device Description : Single-Patient-Use ECG Leadwire Set 3-LEAD, SNAP, AHA, 100 cm/39 in

Device Class : 2

Duns Number: 367919120

Premarket Exempt : No

Product Code : DSA

Prescription Use : Yes

Device Count : 1

Multi-Link - 10885403252068 Catalog Number : 2052104-006

Device Description : Single-Patient-Use ECG Leadwire Set 5-LEAD, SNAP, AHA, 100 cm/39 in

Device Class : 2

Duns Number: 367919120

Premarket Exempt : No

Product Code : DSA

Prescription Use : Yes

Device Count : 1

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