DEVICE: n.a. (04048551052747)
Device Identifier (DI) Information
Device Characteristics
Labeling does not contain MRI Safety Information | |
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No | |
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Yes | |
No | |
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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? |
---|---|---|---|---|
35416 | Oesophageal varices haemostatic tube |
A flexible, hollow cylinder with an inflatable balloon(s) and aspiration port(s) intended to be non-surgically inserted into the oesophagus and stomach, through the nose or mouth, to tampon bleeding oesophageal varices. The device is also known as a Sengstaken, Blakemore, Linton or Minnesota tube. This is a single-use device.
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Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
EOX | ESOPHAGOSCOPE (FLEXIBLE OR RIGID) |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
K943667 | 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
81f41c03-247c-4569-be75-b7bec32295d5
December 23, 2019
4
September 23, 2016
December 23, 2019
4
September 23, 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 |
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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
[?]
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