DEVICE: Axiom® (M665100028XSP0)

Device Identifier (DI) Information

Axiom®
100028XSP
In Commercial Distribution

AXIOM MEDICAL, INCORPORATED
M665100028XSP0
HIBCC

1
094439676 *Terms of Use
Thoracic Catheter, Straight, Silicone
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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?
37482 Pleural catheter
A tube designed to be inserted through an intercostal space and into the pleural cavity to establish a channel for the removal of fluid (pleural effusion, blood, chyle), air (pneumothorax), or pus (empyema) to permit full expansion of the lungs typically after surgery or chest trauma. It is typically used with a pleural drainage system that uses a low negative pressure through the drain lumen. Often referred to as a chest tube, it is typically made of silicone and is available in various designs, shapes, and sizes; it may include disposable devices dedicated to catheter introduction, however it does not include fluid collection bags/containers. This is a single-use device.
Active false
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FDA Product Code

[?]
Product Code Product Code Name
JOL Catheter And Tip, Suction
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K770983 000
No CLOSE

Sterilization

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

[?]
Storage and Handling
No storage/handling found
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Clinically Relevant Size

[?]
Size Type Text
Device Size Text, specify: 28 FR
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Device Record Status

3eef6557-f2a1-4c0e-a8a0-a9220e893b1e
January 03, 2024
4
September 24, 2016
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Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]
Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
M665100028XSP3 10 M665100028XSP1 In Commercial Distribution Case
M665100028XSP1 10 M665100028XSP0 In Commercial Distribution Box
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Secondary DI

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

[?]
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
No
Yes
No
No CLOSE

Customer Contact

[?]
310-533-9020
Sales@AxiomMed.com
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