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

Mouthpiece, Breathing (BYP) (5) Spirometer, Diagnostic (BZG) (3) Meter, Peak Flow, Spirometry (BZH) (2)

Premarket Exempt

No Yes

Clear

Micro Medical - 04250892980249 Catalog Number : 36-SWR1134

Device Description : Spirometry PC Software

Device Class : 2

Duns Number: 291555621

Premarket Exempt : No

Product Code : BZG

Prescription Use : No

Device Count : 1

Micro Medical - 14250892980185 Catalog Number : 36-MTH6410

Device Description : Rubber Flanged Mouthpiece

Device Class : 1

Duns Number: 291555621

Premarket Exempt : Yes

Product Code : BYP

Prescription Use : Yes

Device Count : 1

MicroPeak - 34250892980165 Catalog Number : 36-MPE7200

Device Description : MicroPeak

Device Class : 2

Duns Number: 291555621

Premarket Exempt : No

Product Code : BZH

Prescription Use : Yes

Device Count : 1

MicroPeak - 34250892980172 Catalog Number : 36-MPE8200EU

Device Description : MicroPeak

Device Class : 2

Duns Number: 291555621

Premarket Exempt : No

Product Code : BZH

Prescription Use : Yes

Device Count : 1

Micro Medical - 34250892980196 Catalog Number : 36-SST1000

Device Description : Adult Mouthpieces one way

Device Class : 1

Duns Number: 291555621

Premarket Exempt : Yes

Product Code : BYP

Prescription Use : Yes

Device Count : 1

Micro Medical - 34250892980202 Catalog Number : 36-SST1250

Device Description : Adult Mouthpieces one way

Device Class : 1

Duns Number: 291555621

Premarket Exempt : Yes

Product Code : BYP

Prescription Use : Yes

Device Count : 1

Micro Medical - 34250892980219 Catalog Number : 36-PSA1000

Device Description : Adult Mouthpieces

Device Class : 1

Duns Number: 291555621

Premarket Exempt : Yes

Product Code : BYP

Prescription Use : Yes

Device Count : 1

Micro Medical - 34250892980226 Catalog Number : 36-PSA1200

Device Description : Paediatric Mouthpieces

Device Class : 1

Duns Number: 291555621

Premarket Exempt : Yes

Product Code : BYP

Prescription Use : Yes

Device Count : 1

Spirometry PC Software - 34250892980233 Catalog Number : 36-SPC1000-STK

Device Description : Spirometry PC Software

Device Class : 2

Duns Number: 291555621

Premarket Exempt : No

Product Code : BZG

Prescription Use : Yes

Device Count : 1

Spirometry PC Software Licence - 34250892980257 Catalog Number : 36-SPC0105-STK

Device Description : Spirometry PC Software Licence

Device Class : 2

Duns Number: 291555621

Premarket Exempt : No

Product Code : BZG

Prescription Use : Yes

Device Count : 1

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