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 - 05023323000224 Catalog Number : 3103387

Device Description : MWPFM STD EURO

Device Class : 2

Duns Number: 216155952

Premarket Exempt : Yes

Product Code : BZH

Prescription Use : No

Device Count : 1

Able - 05023323000293 Catalog Number : 3607000

Device Description : ABLE SPACER

Device Class : 2

Duns Number: 216155952

Premarket Exempt : Yes

Product Code : BZH

Prescription Use : No

Device Count : 1

In-Check - 05023323000354 Catalog Number : 3109993

Device Description : IN-CHECK DIAL 6 T&S

Device Class : 2

Duns Number: 216155952

Premarket Exempt : No

Product Code : BZH

Prescription Use : No

Device Count : 1

In-Check - 05023323000361 Catalog Number : 3109751

Device Description : IN-CHECK PFM NASAL MED MASK

Device Class : 2

Duns Number: 216155952

Premarket Exempt : No

Product Code : BZH

Prescription Use : No

Device Count : 1

In-Check - 05023323000408 Catalog Number : 3109750

Device Description : IN-CHECK PFM (ORAL)

Device Class : 2

Duns Number: 216155952

Premarket Exempt : No

Product Code : BZH

Prescription Use : No

Device Count : 1

In-Check - 05023323000804 Catalog Number : 3109831

Device Description : IN-CHECK M

Device Class : 2

Duns Number: 216155952

Premarket Exempt : No

Product Code : BZH

Prescription Use : No

Device Count : 1

In-Check - 05023323000897 Catalog Number : 3109300

Device Description : IN-CHECK DIAL G16

Device Class : 2

Duns Number: 216155952

Premarket Exempt : No

Product Code : BZH

Prescription Use : No

Device Count : 1

Mini Wright - 05023323000941 Catalog Number : 3104124

Device Description : MWPFM AFS EU SCALE L/R W/M CLM

Device Class : 2

Duns Number: 216155952

Premarket Exempt : No

Product Code : BZH

Prescription Use : No

Device Count : 1

Airzone - 05023323001023 Catalog Number : 3130045ATM

Device Description : AIRZONE BLUE ATS ATM SINGLE

Device Class :

Duns Number: 216155952

Premarket Exempt : No

Product Code : BZH

Prescription Use : No

Device Count : 1

Mini Wright - 05023323001078 Catalog Number : 3120010

Device Description : MW DIGITAL FLOW METER (US)

Device Class : 2

Duns Number: 216155952

Premarket Exempt : No

Product Code : BZH

Prescription Use : No

Device Count : 1

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