Home GUDID 05055270988188
Rocket
Primary DI 05055270988188
Brand Rocket
Company ROCKET MEDICAL PLC
Model R53086
Catalog number R53086
Device description URIPOT™ Urine Collection Pack
Published 2023-11-03
Public version status Update
Distribution status Not in Commercial Distribution
MRI safety MR Safe
Sterile true
Single use true
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 05055270988188 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, EAN-13 table Source identifier GTIN-14 normalized EAN-13 05055270988188 05055270988188 5055270988188
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 Kit true Lot or batch true Manufacturing date on label true Expiration date on label true No natural rubber latex true Other Devices From This Company#