DEVICE: Amecath X split catheter (06221139124069)
Device Identifier (DI) Information
Amecath X split catheter
PXDLC-15.519-K
In Commercial Distribution
Ameco Medical Industries
PXDLC-15.519-K
In Commercial Distribution
Ameco Medical Industries
Permthane X split Long term dual lumen catheter kit size 15.5 Fr tip to cuff length 19 Cm total length 24 Cm
Device Characteristics
Labeling does not contain MRI Safety Information | |
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Yes | |
Yes | |
Yes | |
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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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 |
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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: 19 Centimeter |
Catheter Gauge: 15.5 French |
Device Record Status
c3262e57-fb57-418c-bed4-d2a7a234cd81
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