Home GUDID 05055270965745 Rocket
Primary DI 05055270965745
Brand Rocket
Company ROCKET MEDICAL PLC
Model R51400-16-PL
Catalog number R51400-16-PL
Device description Rocket IPC Pleural Insertion Set
Published 2016-09-20
Public version status Update
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx true
OTC false
Sterile true
Single use true Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 05055270965745 Package GS1 5 In Commercial Distribution 05055270965721 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, EAN-13 table Source identifier GTIN-14 normalized EAN-13 05055270965745 05055270965745 5055270965745 05055270965721 05055270965721 5055270965721
GMDN Terms# Term, Definition table Term Definition Multi-purpose percutaneous drainage catheter A sterile 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. It may include disposable devices dedicated to catheter introduction. This is a single-use device.
Device Sizes# Type, Value, Unit table Type Value Unit Catheter Gauge 16 French Length 40 Centimeter
Storage And Handling# Type, Low, High table Type Low High Condition Handling Environment Atmospheric Pressure 101 KiloPascal 101 KiloPascal Handling Environment Humidity 1 Percent (%) Relative Humidity 70 Percent (%) Relative Humidity Handling Environment Temperature -5 Degrees Celsius 40 Degrees Celsius Storage Environment Atmospheric Pressure 101 KiloPascal 101 KiloPascal Storage Environment Humidity 1 Percent (%) Relative Humidity 70 Percent (%) Relative Humidity Storage Environment Temperature -5 Degrees Celsius 30 Degrees Celsius
Regulatory Flags# DUNS number 544313588 Device count 1 DM exempt true Premarket exempt false HCT/P false Kit true Combination product false Lot or batch true Serial number true Manufacturing date on label true Expiration date on label true Donation ID number false Contains natural rubber latex false No natural rubber latex true Sterilization required before use false Other Devices From This Company# 
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