DEVICE: Amecath dual lumen catheter (06221139123802)

Device Identifier (DI) Information

Amecath dual lumen catheter
PDLC-15.535-K
In Commercial Distribution

Ameco Medical Industries
06221139123802
GS1

1
565404779 *Terms of Use
Permthane Long term dual lumen catheter kit size 15.5 Fr tip to cuff length 35 Cm total length 40 Cm
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Device Characteristics

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

[?]
Product Code Product Code Name
MSD Catheter, Hemodialysis, Implanted
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K131814 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
Length: 35 Centimeter
Catheter Gauge: 15.5 French
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Device Record Status

ba4231ec-612d-4048-bb1d-c21ddf40a1ee
February 05, 2021
4
July 31, 2014
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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
No Package DIs found
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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
Yes
No CLOSE

Customer Contact

[?]
2038804091
ray.k@arazygroup.com
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