Home GUDID 05055270955371 Rocket
Primary DI 05055270955371
Brand Rocket
Company ROCKET MEDICAL PLC
Model R53084
Catalog number R53084
Device description Rocket URIPOT Urine Specimen Pack
Published 2017-02-03
Public version status Update
Distribution status In Commercial Distribution
MRI safety MR Safe
Rx false
OTC false
Sterile true
Single use true Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 05055270955371 Package GS1 50 In Commercial Distribution 05055270912589 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, EAN-13 table Source identifier GTIN-14 normalized EAN-13 05055270955371 05055270955371 5055270955371 05055270912589 05055270912589 5055270912589
GMDN Terms# Term, Definition table Term Definition Midstream urine specimen container IVD A covered plastic receptacle with no additives intended to be used for the collection, and preservation and/or transport, of a midstream urine specimen for analysis and/or other investigation. The midstream is collected after an initial pre-measured volume of first-voided urine is diverted to a separate reservoir for discarding. Additional items may be included (e.g., towelettes). This is a single-use device.
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 true 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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