CLEMENT CLARKE INTERNATIONAL 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

Meter, Peak Flow, Spirometry (BZH) (10)

Premarket Exempt

No Yes

Clear

Mini Wright - 05023323001122 Catalog Number : 3103104ATM

Device Description : MWPFM STD ATS ATM SINGLE

Device Class : 2

Duns Number: 216155952

Premarket Exempt : Yes

Product Code : BZH

Prescription Use : No

Device Count : 1

Mini Wright - 05023323001139 Catalog Number : 3104001ATM

Device Description : MWPFM L/R ATS ATM SINGLE

Device Class : 2

Duns Number: 216155952

Premarket Exempt : No

Product Code : BZH

Prescription Use : No

Device Count : 1

In-Check - 05023323001146 Catalog Number : 3109750ATM

Device Description : IN-CHECK ORAL ATM

Device Class : 2

Duns Number: 216155952

Premarket Exempt : No

Product Code : BZH

Prescription Use : No

Device Count : 1

In-Check - 05023323001153 Catalog Number : 3109912ATM

Device Description : IN-CHECK DIAL ATM (INFO)

Device Class : 2

Duns Number: 216155952

Premarket Exempt : No

Product Code : BZH

Prescription Use : No

Device Count : 1

In-Check - 05023323001177 Catalog Number : 3109910

Device Description : IN-CHECK DIAL PIFM INFO SCALE

Device Class : 2

Duns Number: 216155952

Premarket Exempt : No

Product Code : BZH

Prescription Use : No

Device Count : 1

Airzone - 05023323001214 Catalog Number : 3130045

Device Description : AIRZONE BLUE ATS (US) SINGLE

Device Class :

Duns Number: 216155952

Premarket Exempt : No

Product Code : BZH

Prescription Use : No

Device Count : 1

Mini Wright - 05023323001450 Catalog Number : 3103842S

Device Description : MW STD ATS (MEDLINE) SINGLE

Device Class :

Duns Number: 216155952

Premarket Exempt : Yes

Product Code : BZH

Prescription Use : No

Device Count : 1

Mini Wright - 05023323001474 Catalog Number : 3104330S

Device Description : MW AFS ATS (MEDLINE) SINGLE

Device Class :

Duns Number: 216155952

Premarket Exempt : No

Product Code : BZH

Prescription Use : No

Device Count : 1

Mini Wright - 05023323030856 Catalog Number : 3103085

Device Description : MWPFM STD ATS CLAM

Device Class : 2

Duns Number: 216155952

Premarket Exempt : Yes

Product Code : BZH

Prescription Use : No

Device Count : 1

Mini Wright - 05023323040503 Catalog Number : 3104050

Device Description : MWPFM AFS LOW RANGE ATS

Device Class : 2

Duns Number: 216155952

Premarket Exempt : No

Product Code : BZH

Prescription Use : No

Device Count : 1

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