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

SET, TUBING AND SUPPORT, VENTILATOR (W HARNESS) (BZO) (8) MOUTHPIECE, BREATHING (BYP) (2)

Premarket Exempt

No Yes

Clear

Medium Adult mouthpiece 10/bx - 00850644007688 Catalog Number : 1000

Device Description : blue vinyl, 30mm OD, 10/bx

Device Class :

Duns Number: 077967081

Premarket Exempt : Yes

Product Code : BYP

Prescription Use : No

Device Count : 10

Tri-Seal mouthseal 50/bx - 00850644007695 Catalog Number : 1007

Device Description : blue vinyl, 22mm OD, 50/bx

Device Class :

Duns Number: 077967081

Premarket Exempt : Yes

Product Code : BYP

Prescription Use : No

Device Count : 50

Clean-Bor Tube 1-3/8" x 24" - 00850644007701 Catalog Number : 1011-24

Device Description : Clean-Bor Tube

Device Class : 1

Duns Number: 077967081

Premarket Exempt : Yes

Product Code : BZO

Prescription Use : No

Device Count : 1

Clean-Bor Tube 1-3/8" x 24" - 00850644007718 Catalog Number : 1011-24-BULK

Device Description : Clean-Bor Tube

Device Class :

Duns Number: 077967081

Premarket Exempt : Yes

Product Code : BZO

Prescription Use : No

Device Count : 50

Clean-Bor Tube 1-3/8" x 34" - 00850644007725 Catalog Number : 1011-34

Device Description : Clean-Bor Tube

Device Class : 1

Duns Number: 077967081

Premarket Exempt : Yes

Product Code : BZO

Prescription Use : No

Device Count : 1

Clean-Bor Tube 1-3/8" x 34" - 00850644007732 Catalog Number : 1011-34-BULK

Device Description : Clean-Bor Tube

Device Class :

Duns Number: 077967081

Premarket Exempt : Yes

Product Code : BZO

Prescription Use : No

Device Count : 50

Clean-Bor Tube 1-3/8" x 36" - 00850644007749 Catalog Number : 1011-36

Device Description : Clean-Bor Tube

Device Class : 1

Duns Number: 077967081

Premarket Exempt : Yes

Product Code : BZO

Prescription Use : No

Device Count : 1

Clean-Bor Tube 1-3/8" x 47" - 00850644007756 Catalog Number : 1011-47

Device Description : Clean-Bor Tube

Device Class : 1

Duns Number: 077967081

Premarket Exempt : Yes

Product Code : BZO

Prescription Use : No

Device Count : 1

Clean-Bor Tube 1-3/8" x 47" - 00850644007763 Catalog Number : 1011-47-BULK

Device Description : Clean-Bor Tube

Device Class :

Duns Number: 077967081

Premarket Exempt : Yes

Product Code : BZO

Prescription Use : No

Device Count : 50

Clean-Bor Tube 1-3/8" x 60" - 00850644007770 Catalog Number : 1011-60

Device Description : Clean-Bor Tube

Device Class : 1

Duns Number: 077967081

Premarket Exempt : Yes

Product Code : BZO

Prescription Use : No

Device Count : 1

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