Home GUDID 04961333243419 N/A
Primary DI 04961333243419
Brand N/A
Company PENTAX OF AMERICA, INC.
Model KUMOF-B58K
Device description SUCTION VALVE, 2 PCS
Published 2018-03-14
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 FAJ Cystoscope And Accessories, Flexible/Rigid
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class FAJ Cystoscope And Accessories, Flexible/Rigid Gastroenterology, Urology 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 04961333243419 Primary GS1 0 14961333243416 Unit of Use GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, EAN-13 table Source identifier GTIN-14 normalized EAN-13 04961333243419 04961333243419 4961333243419 14961333243416 14961333243416
GMDN Terms# Term, Definition table Term Definition Endoscopic suction valve, reusable A non-sterile device intended to be fitted to an endoscope suction channel to enable the operator to control suction whist preventing inflow of air. It is in the form of an attachable valve that controls (opens/closes) the suction channel. This is a reusable device.
Sterilization Methods# Method table Method "[""Ethylene Oxide"", ""High-level Disinfectant""]" Ethylene Oxide;High-level Disinfectant
Regulatory Flags# DUNS number 083211284 Device count 2 Kit 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 00840432200001 CFlex™ Verathon Medical (Canada) ULC FAJ 2026-05-15 00840432200018 CFlex™ Verathon Medical (Canada) ULC FAJ 2026-05-15 00810116023424 Dornier MedTech DORNIER MEDTECH AMERICA, INC. FAJ 2026-05-06 00850023925381 Aptra Otu Medical Inc. FAJ 2024-09-30 00850023925398 Aptra Otu Medical Inc. FAJ 2024-09-30 00850023925428 WiScope® Otu Medical Inc. FAJ 2024-09-30 00850023925435 WiScope® Otu Medical Inc. FAJ 2024-09-30 04055207038512 RIWO Richard Wolf GmbH FAJ 2024-08-19 04055207008607 NA Richard Wolf GmbH FAJ 2024-08-19 00677964074936 ENDO SMARTCAP MEDIVATORS INC. FAJ 2024-05-29 07613327616675 SPY STRYKER CORPORATION FAJ 2024-02-27 07613327616736 SPY STRYKER CORPORATION FAJ 2024-02-27 10818634025149 Ambu Bosma Enterprises FAJ 2023-05-01 10818634025194 Ambu Bosma Enterprises FAJ 2023-05-01 50724995219241 ENDO SMARTCAP MEDIVATORS INC. FAJ 2023-04-28 50724995219258 ENDO SMARTCAP MEDIVATORS INC. FAJ 2023-04-28 50724995219265 ENDO SMARTCAP MEDIVATORS INC. FAJ 2023-04-28 50724995219272 ENDO SMARTCAP MEDIVATORS INC. FAJ 2023-04-28 00848657076135 AED Flexible Cystoscopy Biopsy Forcep, 1.8mm x 65cm NATIONAL ADVANCED ENDOSCOPY DEVICES, INC. FAJ 2023-01-25 00848657076142 AED Flexible Cystoscopy Alligator Forcep S/A, 1.8mm x 65cm NATIONAL ADVANCED ENDOSCOPY DEVICES, INC. FAJ 2023-01-25 00848657076159 AED Flexible Cystoscopy Alligator Forcep D/A, 1.8mm x 65cm NATIONAL ADVANCED ENDOSCOPY DEVICES, INC. FAJ 2023-01-25 00848657076166 AED Flexible Cystoscopy Rat Tooth Forcep, 1.8mm x 65cm NATIONAL ADVANCED ENDOSCOPY DEVICES, INC. FAJ 2023-01-25 00860008483706 Uro-G Flexible Cystoscope UROVIU CORP. FAJ 2022-12-16 00850006759668 Aveta Auto 5 Fr Disposable Resecting Device MEDITRINA, INC. FAJ 2022-08-18 00850023925169 WiScope® Otu Medical Inc. FAJ 2022-04-18 00850023925176 WiScope® Otu Medical Inc. FAJ 2022-04-18 00850023925183 WiScope® Otu Medical Inc. FAJ 2022-04-18 00850023925190 WiScope® Otu Medical Inc. FAJ 2022-04-18 00853277008084 LUMINELLE Bx 360° Rotatable Disposable Sheath (Biopsy) UVISION 360, INC. FAJ 2021-08-13 00853277008091 LUMINELLE Bx 360° Rotatable Disposable Sheath (Biopsy) UVISION 360, INC. FAJ 2021-08-13