TRANSTRACHEAL SYSTEMS, INC.

TRANSTRACHEAL SYSTEMS, INC.

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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, Tracheostomy (W/Wo Connector) (BTO) (9)

Premarket Exempt

Yes

Clear

SCOOP - B181C110 Catalog Number : C-11

Device Description : Transtracheal Catheter and Cleaning Rod (Single Pack) 11cm

Device Class : 2

Duns Number: 826282220

Premarket Exempt : Yes

Product Code : BTO

Prescription Use : Yes

Device Count : 1

SCOOP - B181C1120 Catalog Number : C-11-2

Device Description : Transtracheal Catheters and Cleaning Rods (Two Pack) 11cm

Device Class : 2

Duns Number: 826282220

Premarket Exempt : Yes

Product Code : BTO

Prescription Use : Yes

Device Count : 1

SCOOP - B181C11HF20 Catalog Number : C-11HF-2

Device Description : Transtracheal Catheters and Cleaning Rods (Two Pack) 11cm

Device Class : 2

Duns Number: 826282220

Premarket Exempt : Yes

Product Code : BTO

Prescription Use : Yes

Device Count : 1

SCOOP - B181C130 Catalog Number : C-13

Device Description : Transtracheal Catheters and Cleaning Rods (Single Pack) 13cm

Device Class : 2

Duns Number: 826282220

Premarket Exempt : Yes

Product Code : BTO

Prescription Use : Yes

Device Count : 1

SCOOP - B181C1320 Catalog Number : C-13-2

Device Description : Transtracheal Catheters and Cleaning Rods (Two Pack) 13cm

Device Class : 2

Duns Number: 826282220

Premarket Exempt : Yes

Product Code : BTO

Prescription Use : Yes

Device Count : 1

SCOOP - B181C13HF20 Catalog Number : C-13HF-2

Device Description : Transtracheal Catheters and Cleaning Rods (Two Pack) 13cm length

Device Class : 2

Duns Number: 826282220

Premarket Exempt : Yes

Product Code : BTO

Prescription Use : Yes

Device Count : 1

SCOOP - B181C90 Catalog Number : C-9

Device Description : Transtracheal Catheter and Cleaning Rod (Single Pack) 9cm

Device Class : 2

Duns Number: 826282220

Premarket Exempt : Yes

Product Code : BTO

Prescription Use : Yes

Device Count : 1

SCOOP - B181C920 Catalog Number : C-9-2

Device Description : Transtracheal Catheters and Cleaning Rods (Two Pack) 9cm

Device Class : 2

Duns Number: 826282220

Premarket Exempt : Yes

Product Code : BTO

Prescription Use : Yes

Device Count : 1

SCOOP - B181C9HF20 Catalog Number : C-9HF-2

Device Description : Transtracheal Catheters and Cleaning Rods (Two Pack) 9cm

Device Class : 2

Duns Number: 826282220

Premarket Exempt : Yes

Product Code : BTO

Prescription Use : Yes

Device Count : 1

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