DEVICE: M-Drain Centesis Catheter (15711055002001)

Device Identifier (DI) Information

M-Drain Centesis Catheter
D40105015
In Commercial Distribution
D40105015
Mermaid Medical A/S
15711055002001
GS1

1
308951313 *Terms of Use
M-Drain Centesis Catheter is used in percutaneous fluid aspirations and small volume drainage procedures.
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Device Characteristics

Labeling does not contain MRI Safety Information
No
Yes
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?
47796 Multi-purpose percutaneous abdominothoracic drainage catheter
A flexible tube intended for percutaneous introduction into two or more abdominothoracic anatomies (nephrostomy, biliary, abscess, pleural, peritoneal, mediastinal) [i.e., multi-purpose] for intermittent or long-term drainage. It is available in various designs, shapes, and sizes, and is often designed to be connected to a pleural/peritoneal cavity suction (drainage) system. Disposable devices dedicated to catheter introduction may be included with the device. This is a single-use device.
Active true
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FDA Product Code

[?]
Product Code Product Code Name
GCB Needle, Catheter
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
Premarket Submission Number Not Available/Not Released
Yes CLOSE

Sterilization

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

[?]
Storage and Handling
Special Storage Condition, Specify: Keep away from sunlight and keep dry
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Clinically Relevant Size

[?]
Size Type Text
Catheter Gauge: 5 French
Length: 15 Centimeter
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Device Record Status

a73d7126-9366-4c15-bbf8-fcd2dd07d620
September 09, 2020
2
August 05, 2019
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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
05711055002004 10 15711055002001 In Commercial Distribution Retail Box
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Secondary DI

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

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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

[?]
+4547108570
customer@mermaidmedical.com
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