ENDURE INDUSTRIES

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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

Tube, Tracheal (W/Wo Connector) (BTR) (10)

Premarket Exempt

No Yes

Clear

Endure - B531ETPOC7060 Catalog Number : ETPOC706

Device Description : Preformed Endotracheal Tube, Oral, Cuffed, Size = 7.0 mm Inner Diameter

Device Class : 2

Duns Number: 066087031

Premarket Exempt : No

Product Code : BTR

Prescription Use : Yes

Device Count : 1

Endure - B531ETPOC7560 Catalog Number : ETPOC756

Device Description : Preformed Endotracheal Tube, Oral, Cuffed, Size = 7.5 mm Inner Diameter, Sterile

Device Class : 2

Duns Number: 066087031

Premarket Exempt : No

Product Code : BTR

Prescription Use : Yes

Device Count : 1

Endure - B531ETPOC8060 Catalog Number : ETPOC806

Device Description : Preformed Endotracheal Tube, Oral, Cuffed, Size = 8.0 mm Inner Diameter

Device Class : 2

Duns Number: 066087031

Premarket Exempt : No

Product Code : BTR

Prescription Use : Yes

Device Count : 1

Endure - B531ETPOU3060 Catalog Number : ETPOU306

Device Description : Endotracheal Tube, Preformed, Oral Type, Uncuffed, Size 3.0 mm Internal Diameter, Sterile

Device Class : 2

Duns Number: 066087031

Premarket Exempt : No

Product Code : BTR

Prescription Use : Yes

Device Count : 1

Endure - B531ETPOU3560 Catalog Number : ETPOU356

Device Description : Endotracheal Tube, Preformed, Oral, Uncuffed, Sterile, Size 3.5 mm Internal Diameter

Device Class : 2

Duns Number: 066087031

Premarket Exempt : No

Product Code : BTR

Prescription Use : Yes

Device Count : 1

Endure - B531ETPOU4060 Catalog Number : ETPOU406

Device Description : Endotracheal Tube, Preformed, Oral Type, Uncuffed, Size 4.0 mm Internal Diameter, Sterile

Device Class : 2

Duns Number: 066087031

Premarket Exempt : No

Product Code : BTR

Prescription Use : Yes

Device Count : 1

Endure - B531ETPOU4560 Catalog Number : ETPOU456

Device Description : Endotracheal Tube, Preformed, Oral, Uncuffed, Size 4.5 mm, Sterile

Device Class : 2

Duns Number: 066087031

Premarket Exempt : No

Product Code : BTR

Prescription Use : Yes

Device Count : 1

Endure - B531ETPOU5060 Catalog Number : ETPOU506

Device Description : Endotracheal Tube, Preformed, Oral Type, Uncuffed, Size 5.0 mm, Sterile

Device Class : 2

Duns Number: 066087031

Premarket Exempt : No

Product Code : BTR

Prescription Use : Yes

Device Count : 1

Endure - B531ETRC7050 Catalog Number : ETRC705

Device Description : Endotracheal Tube, Reinforced Type, Cuffed, Size = 7 mm Inner Diameter.

Device Class : 2

Duns Number: 066087031

Premarket Exempt : No

Product Code : BTR

Prescription Use : Yes

Device Count : 1

Endure - B531ETRC7550 Catalog Number : ETRC755

Device Description : Endotracheal Tube, Reinforced, Cuffed, Size = 7.5 mm Inner Diameter.

Device Class : 2

Duns Number: 066087031

Premarket Exempt : No

Product Code : BTR

Prescription Use : Yes

Device Count : 1

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