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) (9) Analyzer, Gas, Carbon-Monoxide, Gaseous-Phase (CCJ) (1)

Premarket Exempt

No Yes

Clear

Spirometry PC Software Update - 34250892980264 Catalog Number : 36-SPCU100-STK

Device Description : Spirometry PC Software Update

Device Class : 2

Duns Number: 291555621

Premarket Exempt : No

Product Code : BZG

Prescription Use : Yes

Device Count : 1

Micro Medical - 54250892980015 Catalog Number : 36-MC02-STK

Device Description : MicroCO

Device Class : 2

Duns Number: 291555621

Premarket Exempt : No

Product Code : CCJ

Prescription Use : Yes

Device Count : 1

Micro Medical - 54250892980022 Catalog Number : 36-MD03-STK

Device Description : MicroDiary

Device Class : 2

Duns Number: 291555621

Premarket Exempt : No

Product Code : BZG

Prescription Use : Yes

Device Count : 1

Micro Medical - 54250892980039 Catalog Number : 36-ML2525-STK

Device Description : SpiroUSB

Device Class : 2

Duns Number: 291555621

Premarket Exempt : No

Product Code : BZG

Prescription Use : Yes

Device Count : 1

Micro Medical - 54250892980046 Catalog Number : 36-ML3500 MK8-STK

Device Description : MicroLab

Device Class : 2

Duns Number: 291555621

Premarket Exempt : No

Product Code : BZG

Prescription Use : Yes

Device Count : 1

Micro Medical - 54250892980053 Catalog Number : 36-ML3500 MK8-REGION 2&3

Device Description : MicroLab

Device Class : 2

Duns Number: 291555621

Premarket Exempt : No

Product Code : BZG

Prescription Use : Yes

Device Count : 1

Micro Medical - 54250892980060 Catalog Number : 36-ML3500 MK8-REGION4

Device Description : MicroLab

Device Class : 2

Duns Number: 291555621

Premarket Exempt : No

Product Code : BZG

Prescription Use : Yes

Device Count : 1

Micro Medical - 54250892980077 Catalog Number : 36-ML3535 MK8-STK

Device Description : MicroLoop

Device Class : 2

Duns Number: 291555621

Premarket Exempt : No

Product Code : BZG

Prescription Use : Yes

Device Count : 1

Micro Medical - 54250892980084 Catalog Number : 36-PL10-STK/NHANES

Device Description : PulmoLife

Device Class : 2

Duns Number: 291555621

Premarket Exempt : No

Product Code : BZG

Prescription Use : Yes

Device Count : 1

Micro Medical - 54250892980091 Catalog Number : 36-ML3535 MK8-REGION 2&3

Device Description : MicroLoop

Device Class : 2

Duns Number: 291555621

Premarket Exempt : No

Product Code : BZG

Prescription Use : Yes

Device Count : 1

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