DEVICE: Rocket (05055270915481)
Device Identifier (DI) Information
Rocket
R58800-84-30
In Commercial Distribution
R58800-84-30
ROCKET MEDICAL PLC
R58800-84-30
In Commercial Distribution
R58800-84-30
ROCKET MEDICAL PLC
Rocket Ascitex Multipurpose Drainage Set
Device Characteristics
Labeling does not contain MRI Safety Information | |
No | |
Yes | |
Yes | |
No | |
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? |
---|---|---|---|---|
32337 | Abdominal paracentesis needle, single-use |
A sterile, sharp bevel-edged, hollow tubular metal instrument used to perform therapeutic or diagnostic aspiration of fluids/air from the abdominal cavity. It may be used for the placement/operation of a paracentesis catheter or used directly without a catheter. It is typically made of high-grade stainless steel and may have an attached stopcock to control the aspiration process. The device is commonly used to remove ascites fluid from the peritoneal cavity. This is a single-use device.
|
Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
No Product Codes |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
Premarket Submission Number Not Available/Not Released |
Sterilization
Storage and Handling
[?]Storage and Handling |
---|
Storage Environment Temperature: between -5 and 30 Degrees Celsius |
Storage Environment Humidity: between 1 and 70 Percent (%) Relative Humidity |
Handling Environment Atmospheric Pressure: exactly 101 KiloPascal |
Handling Environment Temperature: between -5 and 40 Degrees Celsius |
Storage Environment Atmospheric Pressure: exactly 101 KiloPascal |
Handling Environment Humidity: between 1 and 70 Percent (%) Relative Humidity |
Clinically Relevant Size
[?]Size Type Text |
---|
Length: 30.0 Centimeter |
Catheter Gauge: 8.0 French |
Device Record Status
97611f27-3d6f-4589-8823-07d6e5ac5c7a
March 29, 2018
2
January 09, 2017
March 29, 2018
2
January 09, 2017
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
---|---|---|---|---|---|
05055270958273 | 1 | 05055270915481 | In Commercial Distribution | 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
[?]
+4401914196988
gudid@rocketmedical.com
gudid@rocketmedical.com