DEVICE: VivaSight-DL (07290013745613)
Device Identifier (DI) Information
VivaSight-DL
DLVT39
In Commercial Distribution
DLVT39
E.T. VIEW LTD
DLVT39
In Commercial Distribution
DLVT39
E.T. VIEW LTD
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 Characteristics
Labeling does not contain MRI Safety Information | |
No | |
No | |
Yes | |
Yes | |
No | |
Yes | |
No | |
No |
GMDN
[?]GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.
GMDN Term Code | GMDN Term Name | GMDN Term Definition | GMDN Term Status [?] | Implantable? |
---|---|---|---|---|
31328 | Endobronchial tube |
A hollow cylinder that is designed for oral insertion via the trachea and into a lung to maintain airway patency and/or to deliver anaesthetic inhalation agents or other medical gases, and secure ventilation. It is typically made of plastic, rubber, or silicone and may be packaged with a connector that attaches to a breathing circuit and is available in two basic configurations: 1) a double lumen tube with independent cuffs at the distal end for ventilation of the left or right bronchi; or 2) a twin lumen tube with independent cuffs for selective lung ventilation during thoracic surgery or postoperative care when independent lung ventilation is indicated. This is a single-use device.
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Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
CBI | Tube, Tracheal/Bronchial, Differential Ventilation (W/Wo Connector) |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
K123853 | 000 |
Sterilization
Storage and Handling
[?]Storage and Handling |
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No storage/handling found |
Clinically Relevant Size
[?]Size Type Text |
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No Device Sizes |
Device Record Status
951a11f3-486a-4c6a-8a97-2230b2a0913f
August 15, 2018
4
September 24, 2016
August 15, 2018
4
September 24, 2016
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
---|---|---|---|---|---|
17290013745610 | 5 | 07290013745613 | In Commercial Distribution | carton | |
27290013745617 | 2 | 17290013745610 | In Commercial Distribution | Carton |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
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No Secondary DIs found |
Unit of Use DI
[?]
Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
+972-722607060
medical@ETView.com
medical@ETView.com