DEVICE: Axiom® Atraum™ With ClotStop® (M665111119AT0)
Device Identifier (DI) Information
Axiom® Atraum™ With ClotStop®
111119AT
In Commercial Distribution
AXIOM MEDICAL, INCORPORATED
111119AT
In Commercial Distribution
AXIOM MEDICAL, INCORPORATED
Mediastinal Drain, Silicone, Eyes On Top & Bottom, With ClotStop®
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? |
---|---|---|---|---|
32544 | Mediastinal drainage catheter, non-antimicrobial |
A tube designed to establish a channel for the removal of fluid or purulent material from the mediastinum (the central compartment of the thoracic cavity); it is not coated with an antimicrobial agent. It is typically used in conjunction with, or as a component of, a drainage system that uses a low negative pressure through the drain lumen. It is typically made of silicone, available in various designs, shapes, and sizes, and may include disposable devices dedicated to catheter introduction; it does not include any fluid collection bags/containers. This is a single-use device.
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Active | true |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
GBS | Catheter, Ventricular, General & Plastic Surgery |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
K883887 | 000 |
Sterilization
Storage and Handling
[?]Storage and Handling |
---|
No storage/handling found |
Clinically Relevant Size
[?]Size Type Text |
---|
Device Size Text, specify: 11 mm |
Device Record Status
727c5084-35a6-43ab-990d-ef7622180644
June 19, 2020
2
September 23, 2018
June 19, 2020
2
September 23, 2018
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
---|---|---|---|---|---|
M665111119AT3 | 10 | M665111119AT1 | In Commercial Distribution | Case | |
M665111119AT1 | 10 | M665111119AT0 | In Commercial Distribution | Box |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
---|---|
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
[?]
310-533-9020
Sales@AxiomMed.com
Sales@AxiomMed.com