DEVICE: Amecath dual lumen catheter (06221139123802)
Device Identifier (DI) Information
Amecath dual lumen catheter
PDLC-15.535-K
In Commercial Distribution
Ameco Medical Industries
PDLC-15.535-K
In Commercial Distribution
Ameco Medical Industries
Permthane Long term dual lumen catheter kit size 15.5 Fr tip to cuff length 35 Cm total length 40 Cm
Device Characteristics
Labeling does not contain MRI Safety Information | |
No | |
Yes | |
Yes | |
Yes | |
No | |
Yes | |
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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. The copyright and database rights in the original GMDN materials are owned by The GMDN Agency Ltd 2005-2023. 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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37278 | Double-lumen haemodialysis catheter, implantable |
An implantable, flexible, double-lumen tube intended to be used for chronic or long-term (> 30 days) vascular access, primarily during haemodialysis, to conduct blood from a patient and returning it after extracorporeal circulation; it may also be used during haemoperfusion and/or apheresis. It is intended for coaxial flow of blood, may be radiopaque, coated with heparin to prevent thrombus formation, and/or include a silver-coated sleeve to retard bacterial growth; devices dedicated to catheter introduction/function (e.g., introducer needle) may be included.
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Active | true |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
MSD | Catheter, Hemodialysis, Implanted |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
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K131814 | 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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Length: 35 Centimeter |
Catheter Gauge: 15.5 French |
Device Record Status
ba4231ec-612d-4048-bb1d-c21ddf40a1ee
February 05, 2021
4
July 31, 2014
February 05, 2021
4
July 31, 2014
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
[?]
2038804091
ray.k@arazygroup.com
ray.k@arazygroup.com