Home GUDID 04961333115303
PENTAX
Primary DI 04961333115303
Brand PENTAX
Company HOYA CORPORATION
Model OF-B184
Device description O-Ring Set For OF-B183 OF-B184
Published 2023-07-31
Public version status Update
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx true Product Codes# Code, Name table Code Name FAM Sigmoidoscope And Accessories, Flexible/Rigid
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class FAM Sigmoidoscope And Accessories, Flexible/Rigid Gastroenterology, Urology 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 04961333115303 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, EAN-13 table Source identifier GTIN-14 normalized EAN-13 04961333115303 04961333115303 4961333115303
GMDN Terms# Term, Definition table Term Definition Endoscopic procedure air/water valve, reusable A non-sterile device intended to be fitted to an endoscope air/water channel to enable the operator to control inflow of medical gases [i.e., air, carbon dioxide (CO2)] and/or water whilst preventing backflow. It is in the form of an attachable valve with one or more settings such as closed, insufflation (allowing air/gas in), and irrigation/rinse (allowing water in). This is a reusable device intended to be reprocessed prior to use.
Sterilization Methods# Method table Method "[""High-level Disinfectant"", ""Ethylene Oxide"", ""Moist Heat or Steam Sterilization""]" High-level Disinfectant;Ethylene Oxide;Moist Heat or Steam Sterilization
Regulatory Flags# DUNS number 691519705 Device count 1 DM exempt true Lot or batch true Sterilization required before use true Other Devices From This Company# Other Devices Sharing Product Codes# Primary DI, Brand, Company table Primary DI Brand Company Product code Published 00732094139051 Welch Allyn, Inc. WELCH ALLYN, INC. FAM 2023-08-18 00732094139075 Welch Allyn, Inc. WELCH ALLYN, INC. FAM 2023-08-18 00732094080940 Welch Allyn, Inc. WELCH ALLYN, INC. FAM 2023-08-17 00732094080957 Welch Allyn, Inc. WELCH ALLYN, INC. FAM 2023-08-17 00732094080964 Welch Allyn, Inc. WELCH ALLYN, INC. FAM 2023-08-17 04547410436501 FUJIFILM FUJIFILM CORPORATION FAM 2021-04-27 00732094080384 Welch Allyn, Inc. WELCH ALLYN, INC. FAM 2021-04-26 00732094080391 Welch Allyn, Inc. WELCH ALLYN, INC. FAM 2021-04-14 00732094200300 Welch Allyn, Inc. WELCH ALLYN, INC. FAM 2020-01-16 00732094079678 Welch Allyn, Inc. WELCH ALLYN, INC. FAM 2018-03-01 00732094080933 Welch Allyn, Inc. WELCH ALLYN, INC. FAM 2018-03-01 04961333070831 PENTAX HOYA CORPORATION FAM 2017-04-07 04961333071425 PENTAX HOYA CORPORATION FAM 2017-04-07 04961333228164 PENTAX HOYA CORPORATION FAM 2017-04-07 04961333232635 VIDEO SIGMOIDOSCOPE PENTAX OF AMERICA, INC. FAM 2017-04-06 04961333232642 VIDEO SIGMOIDOSCOPE PENTAX OF AMERICA, INC. FAM 2017-04-06 04547410330977 FUJIFILM FUJIFILM CORPORATION FAM 2016-12-14 04547410333299 FUJIFILM FUJIFILM CORPORATION FAM 2016-12-14 04048551084373 n.a. Karl Storz GmbH & Co. KG FAM 2016-09-23 00732094236958 Welch Allyn, Inc. WELCH ALLYN, INC. FAM 2016-09-20 00732094144024 Welch Allyn, Inc. WELCH ALLYN, INC. FAM 2016-09-20 00732094106046 Welch Allyn, Inc. WELCH ALLYN, INC. FAM 2016-09-19 00732094106060 Welch Allyn, Inc. WELCH ALLYN, INC. FAM 2016-09-17 00732094144000 Welch Allyn, Inc. WELCH ALLYN, INC. FAM 2016-09-17 00749756173520 DeRoyal DEROYAL INDUSTRIES, INC. FAM 2016-09-12 50749756173525 DeRoyal DEROYAL INDUSTRIES, INC. FAM 2016-09-12