Vacumed

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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) (10)

Premarket Exempt

No Yes

Clear

Disposable Mouthpiece 19mm OD - 00850644007169 Catalog Number : 1020-250

Device Description : cardboard mouthpiece

Device Class :

Duns Number: 077967081

Premarket Exempt : Yes

Product Code : BYP

Prescription Use : No

Device Count : 250

Disposable Mouthpiece 19mm OD - 00850644007176 Catalog Number : 1020-100

Device Description : cardboard mouthpiece

Device Class :

Duns Number: 077967081

Premarket Exempt : Yes

Product Code : BYP

Prescription Use : No

Device Count : 100

Disposable Mouthpiece 22mm OD - 00850644007206 Catalog Number : 1021-100

Device Description : cardboard mouthpiece

Device Class :

Duns Number: 077967081

Premarket Exempt : Yes

Product Code : BYP

Prescription Use : No

Device Count : 100

Disposable Mouthpiece 22mm OD - 00850644007213 Catalog Number : 1021-250

Device Description : cardboard mouthpiece

Device Class :

Duns Number: 077967081

Premarket Exempt : Yes

Product Code : BYP

Prescription Use : No

Device Count : 250

Disposable Mouthpiece 35mm OD - 00850644007220 Catalog Number : 1027-100

Device Description : cardboard mouthpiece

Device Class :

Duns Number: 077967081

Premarket Exempt : Yes

Product Code : BYP

Prescription Use : No

Device Count : 100

Disposable Mouthpiece 35mm OD - 00850644007237 Catalog Number : 1027-250

Device Description : cardboard mouthpiece

Device Class :

Duns Number: 077967081

Premarket Exempt : Yes

Product Code : BYP

Prescription Use : No

Device Count : 250

Disposable Mouthpiece 35mm OD - 00850644007244 Catalog Number : 1026-100

Device Description : cardboard mouthpiece

Device Class :

Duns Number: 077967081

Premarket Exempt : Yes

Product Code : BYP

Prescription Use : No

Device Count : 100

Disposable Mouthpiece 35mm OD - 00850644007251 Catalog Number : 1026-250

Device Description : cardboard mouthpiece

Device Class :

Duns Number: 077967081

Premarket Exempt : Yes

Product Code : BYP

Prescription Use : No

Device Count : 250

Disposable Mouthpiece 30mm OD - 00850644007268 Catalog Number : 1025-100

Device Description : cardboard mouthpiece

Device Class :

Duns Number: 077967081

Premarket Exempt : Yes

Product Code : BYP

Prescription Use : No

Device Count : 100

Disposable Mouthpiece 30mm OD - 00850644007275 Catalog Number : 1025-250

Device Description : cardboard mouthpiece

Device Class :

Duns Number: 077967081

Premarket Exempt : Yes

Product Code : BYP

Prescription Use : No

Device Count : 250

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