Home GUDID 10840861102393 CitraSure™
Primary DI 10840861102393
Brand CitraSure™
Company Fresenius Medical Care Renal Therapies Group, LLC
Model 28-0600-0
Published 2024-04-04
Public version status New
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx true
OTC false
Sterile false
Single use true Product Codes# Code, Name table Code Name NII Disinfectant, Dialysate Delivery System
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class NII Disinfectant, Dialysate Delivery System Gastroenterology, Urology 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 10840861102393 Package GS1 2 In Commercial Distribution 00840861102396 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, UPC-A table Source identifier GTIN-14 normalized UPC-A EAN-13 10840861102393 10840861102393 00840861102396 00840861102396 840861102396 0840861102396
GMDN Terms# Term, Definition table Term Definition Medical device disinfection agent A non-patient-contact substance containing a chemical agent(s) intended to destroy microorganisms or inhibit their activity (disinfectant) on medical instrumentation, equipment, and/or facility surfaces (excluding use on contact lenses). It may contain surfactants/cleaning agents or enzymes (e.g., protease, lipase), and may be intended to decalcify equipment. The medical device is intended to be exposed to the substance to achieve disinfection through bathing, wiping, and/or in combination with a disinfection device. It is available in liquid, aerosol, powder, or tablet form; it is not supplied in a dedicated wipe, cap, or other contact-application carrier.
Device Sizes# Type, Value, Unit table Type Value Unit Total Volume 5 Liter
Storage And Handling# Type, Low, High table Type Low High Condition Storage Environment Temperature 5 Degrees Celsius 30 Degrees Celsius
Regulatory Flags# DUNS number 079732391 Device count 1 DM exempt false Premarket exempt false HCT/P false Kit false Combination product false Lot or batch true Serial number false Manufacturing date on label false Expiration date on label true Donation ID number false Contains natural rubber latex false No natural rubber latex false Sterilization required before use false Other Devices From This Company# Other Devices Sharing Product Codes# Primary DI, Brand, Company table Primary DI Brand Company Product code Published 00840861102723 CitraSure Fresenius Medical Care Renal Therapies Group, LLC NII 2025-07-31 10840861102720 CitraSure Fresenius Medical Care Renal Therapies Group, LLC NII 2025-07-31 00840861102396 CitraSure™ Fresenius Medical Care Renal Therapies Group, LLC NII 2024-04-04 00817492021815 NA MAR COR PURIFICATION, INC. NII 2017-04-06 00817492021297 NA MAR COR PURIFICATION, INC. NII 2016-09-23
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