DEVICE: M-Drain Centesis Catheter (15711055002001)
Device Identifier (DI) Information
M-Drain Centesis Catheter
D40105015
In Commercial Distribution
D40105015
Mermaid Medical A/S
D40105015
In Commercial Distribution
D40105015
Mermaid Medical A/S
M-Drain Centesis Catheter is used in percutaneous fluid aspirations and small volume drainage procedures.
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 |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
GCB | Needle, Catheter |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
Premarket Submission Number Not Available/Not Released |
Sterilization
Storage and Handling
[?]Storage and Handling |
---|
Special Storage Condition, Specify: Keep away from sunlight and keep dry |
Clinically Relevant Size
[?]Size Type Text |
---|
Catheter Gauge: 5 French |
Length: 15 Centimeter |
Device Record Status
a73d7126-9366-4c15-bbf8-fcd2dd07d620
September 09, 2020
2
August 05, 2019
September 09, 2020
2
August 05, 2019
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 |
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
[?]
+4547108570
customer@mermaidmedical.com
customer@mermaidmedical.com