Home GUDID 04580826928611 PENTAX Medical
Primary DI 04580826928611
Brand PENTAX Medical
Company PENTAX MEDICAL CORPORATION
Model OF-B184
Device description O-Ring Set For OF-B183 OF-B184
Published 2026-08-25
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 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 04580826928611 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, EAN-13 table Source identifier GTIN-14 normalized EAN-13 04580826928611 04580826928611 4580826928611
GMDN Terms# Term, Definition table Term Definition Endoscope air/water valve, reusable A 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 Ethylene Oxide High-level Disinfectant Moist Heat or Steam Sterilization
Regulatory Flags# DUNS number 691559848 Device count 1 DM exempt true 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 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# Other Devices Sharing Product Codes# Primary DI, Brand, Company table Primary DI Brand Company Product code Published 04580826926945 PENTAX Medical PENTAX MEDICAL CORPORATION FAM 2026-08-25 04580826927058 PENTAX Medical PENTAX MEDICAL CORPORATION FAM 2026-08-25 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 04961333115303 PENTAX HOYA CORPORATION FAM 2023-07-31 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