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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) (6) Tube, Tracheal/Bronchial, Differential Ventilation (W/Wo Connector) (CBI) (5) Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms) (MHX) (1)

Premarket Exempt

Clear

VivaSight-SL - 07290013745002 Catalog Number : TVT70100

Device Description : Oral/Nasal Cuffed visualization Endotracheal tube

Device Class :

Duns Number: 534096359

Premarket Exempt : No

Product Code : BTR

Prescription Use : Yes

Device Count : 1

VivaSight-SL - 07290013745019 Catalog Number : TVT75105

Device Description : Oral/Nasal Cuffed visualization Endotracheal tube

Device Class :

Duns Number: 534096359

Premarket Exempt : No

Product Code : BTR

Prescription Use : Yes

Device Count : 1

VivaSight-SL - 07290013745026 Catalog Number : TVT80110

Device Description : Oral/Nasal Cuffed visualization Endotracheal tube

Device Class :

Duns Number: 534096359

Premarket Exempt : No

Product Code : BTR

Prescription Use : Yes

Device Count : 1

VivaSight-Direct - 07290013745286 Catalog Number : SA00013

Device Description : RCA cable kit

Device Class :

Duns Number: 534096359

Premarket Exempt : No

Product Code :

Prescription Use : Yes

Device Count : 1

VivaSight-Max - 07290013745293 Catalog Number : SA00014

Device Description : Monitor.

Device Class : 2

Duns Number: 534096359

Premarket Exempt : No

Product Code : MHX

Prescription Use : Yes

Device Count : 1

VivaSight-EB - 07290013745514 Catalog Number : EBB09700

Device Description : Endobronchial blocker.

Device Class :

Duns Number: 534096359

Premarket Exempt : No

Product Code : CBI

Prescription Use : Yes

Device Count : 1

VivaSight Pack - 07290013745545 Catalog Number : TVEB70100

Device Description : A kit wich contains one sterile packed VivaSight SL (Oral/Nasal Cuffed visualiza A kit wich contains one sterile packed VivaSight SL (Oral/Nasal Cuffed visualization Endotracheal tube)and one Sterile packed VivaSight EB (Endobronchial blocker).

Device Class : 2

Duns Number: 534096359

Premarket Exempt : No

Product Code : CBI, BTR

Prescription Use : Yes

Device Count : 1

VivaSight Pack - 07290013745552 Catalog Number : TVEB75105

Device Description : Oral/Nasal Cuffed visualization Endotracheal tube+Endobronchial blocker.

Device Class :

Duns Number: 534096359

Premarket Exempt : No

Product Code : CBI, BTR

Prescription Use : Yes

Device Count : 1

VivaSight Pack - 07290013745569 Catalog Number : TVEB80110

Device Description : Oral/Nasal Cuffed visualization Endotracheal tube+Endobronchial blocker.

Device Class :

Duns Number: 534096359

Premarket Exempt : No

Product Code : CBI, BTR

Prescription Use : Yes

Device Count : 1

VivaSight-DL - 07290013745590 Catalog Number : DLVT35

Device Description : Visualized double lumen endobronchial tube set. the set contains 1 DL tube +two Visualized double lumen endobronchial tube set. the set contains 1 DL tube +two pouches of suction catheter straight and two pouches of suction catheter curved

Device Class :

Duns Number: 534096359

Premarket Exempt : No

Product Code : CBI

Prescription Use : Yes

Device Count : 1

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