DEVICE: Rocket (05055270965721)
Device Identifier (DI) Information
Rocket
R51400-16-PL
In Commercial Distribution
R51400-16-PL
ROCKET MEDICAL PLC
R51400-16-PL
In Commercial Distribution
R51400-16-PL
ROCKET MEDICAL PLC
Rocket IPC Pleural Insertion Set
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? |
---|---|---|---|---|
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.
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Active | true |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
No Product Codes |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
K123033 | 000 |
Sterilization
Storage and Handling
[?]Storage and Handling |
---|
Handling Environment Humidity: between 1 and 70 Percent (%) Relative Humidity |
Storage Environment Temperature: between -5 and 30 Degrees Celsius |
Storage Environment Humidity: between 1 and 70 Percent (%) Relative Humidity |
Handling Environment Temperature: between -5 and 40 Degrees Celsius |
Storage Environment Atmospheric Pressure: exactly 101 KiloPascal |
Handling Environment Atmospheric Pressure: exactly 101 KiloPascal |
Clinically Relevant Size
[?]Size Type Text |
---|
Length: 40.0 Centimeter |
Catheter Gauge: 16.0 French |
Device Record Status
979307d9-6f1e-48f2-a809-4ff948c1956f
September 09, 2020
4
September 20, 2016
September 09, 2020
4
September 20, 2016
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
---|---|---|---|---|---|
05055270965745 | 5 | 05055270965721 | In Commercial Distribution |
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
[?]
+4401914196988
gudid@rocketmedical.com
gudid@rocketmedical.com