Home GUDID 34547410079167 FUJIFILM
Primary DI 34547410079167
Brand FUJIFILM
Company FUJIFILM CORPORATION
Model BA-1
Device description This product is intended to attach the balloon to the distal end of FUJIFILM ultrasound bronchoscope.
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 34547410079167 Package GS1 1 In Commercial Distribution 04547410079166 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, EAN-13 table Source identifier GTIN-14 normalized EAN-13 34547410079167 34547410079167 04547410079166 04547410079166 4547410079166
GMDN Terms# Term, Definition table Term Definition Endoscope balloon positioner, reusable A hand-held manual device exclusively intended to mount an endoscope balloon or endoscope balloon connector (typically a flexible rubber band) onto the distal end of an endoscope prior to balloon inflation; the balloon and connector are not included. It is available in various designs (e.g., tweezer-, pistol- or cone-like with pointed tip). 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 High-level Disinfectant;Ethylene Oxide;Moist Heat or Steam Sterilization
Regulatory Flags# DUNS number 713565195 Device count 1 DM exempt false 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 04573596201367 OASIS MR-NVC-120 OASIS RAPID NV Coil MR-NVC-120 2026-05-29 04573596201398 OASIS MR-QFC-120 OASIS QD Flexible Body Coil(L) MR-QFC-120 2026-05-29 04573596201404 OASIS MR-QFC-120XL OASIS QD Flexible Body Coil(XL) MR-QFC-120XL 2026-05-29 04573596201411 OASIS MR-RFC-120 OASIS RAPID Foot Coil MR-RFC-120 2026-05-29 04573596201435 OASIS MR-CTL-120 OASIS CTL Coil MR-CTL-120 2026-05-29 04573596202159 OASIS MR-IBC-120 OASIS RAPID Breast Coil MR-IBC-120 2026-05-29 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
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