Home GUDID 34547410095587 FUJIFILM
Primary DI 34547410095587
Brand FUJIFILM
Company FUJIFILM CORPORATION
Model CA-500N
Device description This product is exclusively used for manual cleaning and manual disinfection of a FUJIFILM endoscope in medical facilities. Do not use this product for any other purpose.
Published 2022-10-07
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 false Product Codes# Code, Name table Code Name FFY Adaptor, bulbs, miscellaneous, for endoscope
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class FFY Adaptor, Bulbs, Miscellaneous, For Endoscope Gastroenterology, Urology 1
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 34547410095587 Package GS1 1 In Commercial Distribution 24547410095580 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized table Source identifier GTIN-14 normalized 34547410095587 34547410095587 24547410095580 24547410095580
GMDN Terms# Term, Definition table Term Definition Endoscope flushing adaptor, reusable A small attachment designed to be fitted to an endoscope port for flushing of the endoscope’s lumen(s) during post-procedural washing, disinfection and/or sterilization. It is in the form of a plug that may include a button/switch for control of fluid (e.g., sterilant, disinfectant) and/or air through the lumen; it does not include tubing (i.e., not a tubing set). This is a reusable device.
Storage And Handling# Type, Low, High table Type Low High Condition Handling Environment Atmospheric Pressure 70 KiloPascal 106 KiloPascal Handling Environment Humidity 30 Percent (%) Relative Humidity 85 Percent (%) Relative Humidity Handling Environment Temperature 10 Degrees Celsius 40 Degrees Celsius Special Storage Condition, Specify 0 0 There must be no condensation. Storage Environment Atmospheric Pressure 70 KiloPascal 106 KiloPascal Storage Environment Humidity 10 Percent (%) Relative Humidity 85 Percent (%) Relative Humidity Storage Environment Temperature -20 Degrees Celsius 60 Degrees Celsius
Sterilization Methods# Method table Method Ethylene Oxide;Moist Heat or Steam Sterilization;High-level Disinfectant
Regulatory Flags# DUNS number 713565195 Device count 1 DM exempt true Premarket exempt true HCT/P false Kit false Combination product false Lot or batch true Serial number false Manufacturing date on label true Expiration date on label false Donation ID number false Contains natural rubber latex false No natural rubber latex false Sterilization required before use true Other Devices From This Company# Primary DI, Brand, Model table Primary DI Brand Model Catalog Published 04547410480269 FUJIFILM VS-1000 2026-05-22 04547410529128 FUJIFILM EG-S100XT 2026-05-22 04573596200865 APERTO Lucent MR-JCR-82 Joint coil (M) MR-JCR-82 for APERTO Lucent/APEROT 2026-05-22 04573596200889 APERTO Lucent MR-JC-81 Joint coil (S) MRJC-81 for APERTO Lucent/APERTO Et 2026-05-22 04573596200896 APERTO Lucent MR-JCR-83 Joint coil (L) MR-JCR-83 for APERTO Lucent/APEROT 2026-05-22 04573596200902 APERTO Lucent MR-CSC-81 C-Spine coil MR-SCS-81 for APERTO Lucent/APERTO Et 2026-05-22 04573596200940 APERTO Lucent MR-QWC-81 Wrist coil MR-QWC-81 for APERTO Lucent/Aperto Eter 2026-05-22 04573596200964 APERTO Lucent MR-MSC-81 Shoulder coil MR-MSC-81 for APERTO Lucent/APERTO E 2026-05-22 04573596200971 APERTO Lucent MR-QRC-81 Head coil (L) MR-QRC-81 for APERTO Lucent/APERTO E 2026-05-22 04573596201480 APERTO Lucent MR-QHC-81R QD Head coil R MR-QHC-81R for APERTO Lucent 2026-05-22 04573596201497 APERTO Lucent MR-QKC-83R QD Knee coil R MR-QKC-83R for APERTO Lucent 2026-05-22 04573596201503 APERTO Lucent MR-IBC-83 Open body coil MR-IBC-83 for APERTO Lucent/APERTO 2026-05-22 04573596202210 APERTO Lucent MR-QFC-82N Flexible Body coil N(M) MR-QFC-82N for APERTO Luce 2026-05-22 04573596202227 APERTO Lucent MR-QFC-83N Flexible Body coil N(L) MR-QFC-83N for APERTO Luce 2026-05-22 04573596200704 APERTO Lucent APERTO Lucent APERTO Lucent 2024-09-19 04547410334494 Fujifilm Diathermic Slitter (FlushKnife) DK2618J -B15- 2016-09-16 04547410334500 Fujifilm Diathermic Slitter (FlushKnife) DK2618J -B20- 2016-09-16 04547410334517 Fujifilm Diathermic Slitter (FlushKnife) DK2618J -B25- 2016-09-16 04547410334524 Fujifilm Diathermic Slitter (FlushKnife) DK2618J -B30- 2016-09-16 04547410334531 Fujifilm Diathermic Slitter (FlushKnife) DK2618J -N10- 2016-09-16
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