DEVICE: Rocket (05055270900043)
Device Identifier (DI) Information
Rocket
R54410-00-DL
In Commercial Distribution
R54410-00-DL
ROCKET MEDICAL PLC
R54410-00-DL
In Commercial Distribution
R54410-00-DL
ROCKET MEDICAL PLC
Rocket IPC Drainage Line
Device Characteristics
MR Safe | |
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. Used under licence from The GMDN Agency Ltd.
GMDN Term Code | GMDN Term Name | GMDN Term Definition | GMDN Term Status [?] | Implantable? |
---|---|---|---|---|
46215 | Pleural drainage system fluid collector |
A sterile device that is a component of a pleural drainage system and used for the collection of abnormal fluid accumulation (e.g., effusions) from the pleural cavity. It has an integral three-chambered construction; these are the drainage chamber, the suction control chamber and a water seal (underwater) chamber. It is connected to the patient by means of a thoracic drain tube and a suction system regulator, typically connected to the central vacuum system, provides the suction. It is usually employed to restore normal lung function following chest or mediastinal surgery (open heart surgery) or for medical conditions, e.g., pneumothorax and/or haemothorax. This is a single-use device.
|
Obsolete | false |
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 Atmospheric Pressure: exactly 101 KiloPascal |
Storage Environment Temperature: between -5 and 30 Degrees Celsius |
Storage Environment Humidity: between 1 and 70 Percent (%) Relative Humidity |
Storage Environment Atmospheric Pressure: exactly 101 KiloPascal |
Handling Environment Temperature: between -5 and 40 Degrees Celsius |
Handling Environment Humidity: between 1 and 70 Percent (%) Relative Humidity |
Clinically Relevant Size
[?]Size Type Text |
---|
No Device Sizes |
Device Record Status
a3dad8c1-1299-431c-a4c6-dfbfc5f66cd6
July 06, 2018
3
September 08, 2016
July 06, 2018
3
September 08, 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 |
---|---|---|---|---|---|
05055270942838 | 12 | 05055270921437 | In Commercial Distribution | ||
05055270921437 | 10 | 05055270900043 | 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