DEVICE: SILBRONCHO (RIGHT LUNG) (04544050083928)
Device Identifier (DI) Information
SILBRONCHO (RIGHT LUNG)
#33
In Commercial Distribution
1203633
FUJI SYSTEMS CORPORATION
#33
In Commercial Distribution
1203633
FUJI SYSTEMS CORPORATION
SILBRONCHO Tube is intended for use in airway management of surgical patients to perform one-lung ventilation in thoracic surgery, lung resection, VATS, lobectomy and etc.
Device Characteristics
Labeling does not contain MRI Safety Information | |
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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? |
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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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FDA Product Code
[?]Product Code | Product Code Name |
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CBI | Tube, Tracheal/Bronchial, Differential Ventilation (W/Wo Connector) |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
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K051522 | 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
44fcac06-e24f-40f3-8adc-986cc1c08925
July 06, 2018
3
September 24, 2015
July 06, 2018
3
September 24, 2015
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
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No Package DIs found |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
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No Secondary DIs found |
Unit of Use DI
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Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
No Customer Contact currently defined