DEVICE: Rocket (05055270965721)

Device Identifier (DI) Information

Rocket
R51400-16-PL
In Commercial Distribution
R51400-16-PL
ROCKET MEDICAL PLC
05055270965721
GS1

1
544313588 *Terms of Use
Rocket IPC Pleural Insertion Set
CLOSE

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.
Active true
CLOSE

FDA Product Code

[?]
Product Code Product Code Name
No Product Codes
CLOSE

FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K123033 000
No CLOSE

Sterilization

Yes
No
Sterilization Method [?]
No Sterilization Methods Found
CLOSE

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
CLOSE

Clinically Relevant Size

[?]
Size Type Text
Length: 40.0 Centimeter
Catheter Gauge: 16.0 French
CLOSE

Device Record Status

979307d9-6f1e-48f2-a809-4ff948c1956f
September 09, 2020
4
September 20, 2016
CLOSE

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
CLOSE

Secondary DI

[?]
Issuing Agency [?] Secondary DI Number
No Secondary DIs found
CLOSE

Unit of Use DI

[?]
Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]
Yes
No
None
CLOSE

Production Identifier(s) in UDI

[?]
Yes
Yes
Yes
Yes
No CLOSE

Customer Contact

[?]
+4401914196988
gudid@rocketmedical.com
CLOSE