DEVICE: Pylant Monitor (00860010850909)
Device Identifier (DI) Information
Pylant Monitor
IM-1000
In Commercial Distribution
Kal-Med, LLC
IM-1000
In Commercial Distribution
Kal-Med, LLC
Pylant Monitor - Disposable endotracheal tube cuff pressure monitor (15 units per box) - non AC-powered.
Device Characteristics
Labeling does not contain MRI Safety Information | |
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No | |
Yes | |
Yes | |
No | |
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? |
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36877 | Artificial airway tube cuff pressure monitor |
A mains electricity (AC-powered) device intended to intermittently or continuously measure the internal pressure in the cuff of an endotracheal (ET)/endobronchial/tracheostomy tube when this has been situated into the tracheal passage. Too high a cuff pressure and/or combined long periods of use can be damaging for the pressure site on the tracheal wall. It will provide and display a continuous monitoring of the situation which the anaesthetist can observe. Some types may also include the ability to inflate the cuff and regulate the pressure therein.
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Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
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BSK | Cuff, Tracheal Tube, Inflatable |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
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K191858 | 000 |
Sterilization
Storage and Handling
[?]Storage and Handling |
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Special Storage Condition, Specify: Clean & dry temperature controlled location out of sunlight |
Clinically Relevant Size
[?]Size Type Text |
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No Device Sizes |
Device Record Status
40ce7b5b-0b60-4d7c-a53d-950f0d193130
September 11, 2023
1
September 01, 2023
September 11, 2023
1
September 01, 2023
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
[?]
(585) 633-4225
Support@KalMed.net
Support@KalMed.net