CAREFUSION U.K. 232 LIMITED

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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

Spirometer, Diagnostic (BZG) (4) Analyzer, Gas, Carbon-Monoxide, Gaseous-Phase (CCJ) (1) Monitor, Airway Pressure (Includes Gauge And/Or Alarm) (CAP) (1)

Premarket Exempt

No Yes

Clear

Micro Medical - 54250892980107 Catalog Number : 36-ML3535 MK8-REGION4

Device Description : MicroLoop

Device Class : 2

Duns Number: 291555621

Premarket Exempt : No

Product Code : BZG

Prescription Use : Yes

Device Count : 1

Micro Medical - 54250892980114 Catalog Number : 36-MS10-STK

Device Description : Micro I

Device Class : 2

Duns Number: 291555621

Premarket Exempt : No

Product Code : BZG

Prescription Use : Yes

Device Count : 1

Micro Medical - 54250892980121 Catalog Number : 36-PL10-STK/ECCS

Device Description : PulmoLife

Device Class : 2

Duns Number: 291555621

Premarket Exempt : No

Product Code : BZG

Prescription Use : Yes

Device Count : 1

Micro Medical - 54250892980138 Catalog Number : 36-RPM01-STK

Device Description : MicroRPM

Device Class : 2

Duns Number: 291555621

Premarket Exempt : No

Product Code : CAP

Prescription Use : Yes

Device Count : 1

Micro Medical - 54250892980145 Catalog Number : 36-SC01-STK

Device Description : SmokeCheck

Device Class : 2

Duns Number: 291555621

Premarket Exempt : No

Product Code : CCJ

Prescription Use : Yes

Device Count : 1

Micro Medical - 54250892980152 Catalog Number : 36-PL10-STK/ASIAN

Device Description : PulmoLife

Device Class : 2

Duns Number: 291555621

Premarket Exempt : No

Product Code : BZG

Prescription Use : Yes

Device Count : 1

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