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) (6) ANALYZER, GAS, CARBON-DIOXIDE, GASEOUS-PHASE (CCK) (2) ELECTRODE, CIRCULAR (SPIRAL), SCALP AND APPLICATOR (HGP) (1) Warmer, Infant Radiant (FMT) (1)

Premarket Exempt

Yes No

Clear

Multi-Link - 10885403252075 Catalog Number : 2052104-007

Device Description : Single-Patient-Use ECG Leadwire Set 5-LEAD, SNAP, AHA, 75 cm/29 in

Device Class : 2

Duns Number: 367919120

Premarket Exempt : No

Product Code : DSA

Prescription Use : Yes

Device Count : 1

Multi-Link - 10885403252082 Catalog Number : 2052104-008

Device Description : Single-Patient-Use ECG Leadwire Set V-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 - 10885403252112 Catalog Number : 2052133-005

Device Description : Single-Patient-Use ECG Leadwire Set 3-LEAD, GRABBER, 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 - 10885403252129 Catalog Number : 2052133-006

Device Description : Single-Patient-Use ECG Leadwire Set 5-LEAD, GRABBER, 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 - 10885403252136 Catalog Number : 2052133-007

Device Description : Single-Patient-Use ECG Leadwire Set 5-LEAD, GRABBER, AHA, 75 cm/29 in

Device Class : 2

Duns Number: 367919120

Premarket Exempt : No

Product Code : DSA

Prescription Use : Yes

Device Count : 1

Multi-Link - 10885403252143 Catalog Number : 2052133-008

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

Device Class : 2

Duns Number: 367919120

Premarket Exempt : No

Product Code : DSA

Prescription Use : Yes

Device Count : 1

N/A - 10885403252204 Catalog Number : 2464AAO

Device Description : Leg Attachment Pad for Corometrics™ Fetal Scalp Electrode Cable

Device Class : 2

Duns Number: 367919120

Premarket Exempt : No

Product Code : HGP

Prescription Use : Yes

Device Count : 1

AirLife - 10885403252259 Catalog Number : 6600-0208-700

Device Description : Infant Skin Temperature Probe, Single Patient Use, (Lullaby™, Care Plus™)

Device Class : 2

Duns Number: 367919120

Premarket Exempt : No

Product Code : FMT

Prescription Use : Yes

Device Count : 1

Vital Signs - 10885403252686 Catalog Number : 2013066-001

Device Description : Adult Nasal CO2 Sampling Cannula for CapnoFlex Module

Device Class : 2

Duns Number: 367919120

Premarket Exempt : No

Product Code : CCK

Prescription Use : Yes

Device Count : 1

Vital Signs - 10885403252693 Catalog Number : 2013066-003

Device Description : Infant/Neonatal Nasal CO2 Sampling Cannula for CapnoFlex Module

Device Class : 2

Duns Number: 367919120

Premarket Exempt : No

Product Code : CCK

Prescription Use : Yes

Device Count : 1

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