DEVICE: Pylant Monitor (00860010850909)

Device Identifier (DI) Information

Pylant Monitor
IM-1000
In Commercial Distribution

Kal-Med, LLC
00860010850909
GS1

1
792118049 *Terms of Use
Pylant Monitor - Disposable endotracheal tube cuff pressure monitor (15 units per box) - non AC-powered.
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
Yes
Yes
No
No
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?
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.
Active false
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FDA Product Code

[?]
Product Code Product Code Name
BSK Cuff, Tracheal Tube, Inflatable
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K191858 000
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Sterilization

No
No
Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

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Storage and Handling
Special Storage Condition, Specify: Clean & dry temperature controlled location out of sunlight
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Clinically Relevant Size

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Size Type Text
No Device Sizes
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Device Record Status

40ce7b5b-0b60-4d7c-a53d-950f0d193130
September 11, 2023
1
September 01, 2023
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Alternative and Additional Identifiers Additional Identifiers

Package DI

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Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
No Package DIs found
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Secondary DI

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Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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Unit of Use DI

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Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]
No
No
None
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Production Identifier(s) in UDI

[?]
Yes
Yes
Yes
Yes
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Customer Contact

[?]
(585) 633-4225
Support@KalMed.net
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