{ "format": "devicerts.device.v1", "cite_as": "Washing Case Maj-827, Olympus Medical Systems Corporation. deviCERTS medical device catalogue. https://devicerts.com/devices/washing-case-6808900 (data as of 2026-11-15).", "source": { "canonical_url": "https://devicerts.com/devices/washing-case-6808900", "json_url": "https://devicerts.com/devices/washing-case-6808900.json", "markdown_url": "https://devicerts.com/devices/washing-case-6808900.md", "publisher": "deviCERTS (devicerts.com)", "data_sources": [ { "registry": "FDA GUDID (AccessGUDID)", "url": "https://accessgudid.nlm.nih.gov/" }, { "registry": "FDA recalls", "url": "https://open.fda.gov/apis/device/recall/" } ], "registry_records_last_synced": "2026-10-23", "status_as_of": "2026-11-15", "license": "CC BY 4.0", "license_url": "https://creativecommons.org/licenses/by/4.0/", "license_scope": "The deviCERTS layout and text are licensed under CC BY 4.0. Registry data remain under their source terms: U.S. FDA data (openFDA, AccessGUDID) are U.S. public domain; EUDAMED data are subject to the European Commission reuse terms.", "attribution": "DevicErts, https://devicerts.com/devices/washing-case-6808900", "disclaimer": "Compiled by deviCERTS (devicerts.com) from public medical device registries (EUDAMED, European Commission; U.S. FDA via openFDA; AccessGUDID, U.S. National Library of Medicine). deviCERTS is not an official register and gives no regulatory advice: the record in the registry itself prevails." }, "device": { "name": "Washing Case Maj-827", "registry_name": "WASHING CASE MAJ-827", "url": "https://devicerts.com/devices/washing-case-6808900", "manufacturer": { "name": "Olympus Medical Systems Corporation", "url": "https://devicerts.com/manufacturers/olympus-medical-systems-corporation", "country": null, "country_basis": null, "fda_registration_country": "Japan" }, "status": { "state": "active", "label": "Active", "detail": "United States" }, "classification": [ { "class": "Class II", "system": "US FDA" } ], "identifiers": [ { "label": "Catalogue number", "values": [ { "value": "6808900", "registries": [ "FDA GUDID (AccessGUDID)" ] } ] }, { "label": "Primary DI / UDI-DI", "values": [ { "value": "04953170069512", "registries": [ "FDA GUDID (AccessGUDID)" ] } ] } ], "product_codes": [ "FEB" ], "emdn": [], "gmdn": [ { "code": "62151", "term": "Sterilizer/disinfector rack" } ], "description": null, "noindex": true }, "authorizations": [ { "registry": "GUDID", "region": "United States", "type": "GUDID listing", "number": "04953170069512", "number_label": "UDI-DI", "device_udi_di": null, "date": "2016-09-21", "date_kind": "listed", "decision_code": null, "expires": null, "withdrawn": null, "status": "Listed", "status_note": "GUDID: not in commercial distribution", "derived_from_gudid": false }, { "registry": "GUDID", "region": "United States", "type": "FDA 510(k)", "number": "K120357", "number_label": null, "device_udi_di": null, "date": "2012-12-20", "date_kind": "decision", "decision_code": "SESE", "expires": null, "withdrawn": null, "status": "Active", "status_note": null, "derived_from_gudid": true }, { "registry": "GUDID", "region": "United States", "type": "FDA 510(k)", "number": "K103264", "number_label": null, "device_udi_di": null, "date": "2011-02-23", "date_kind": "decision", "decision_code": "SESE", "expires": null, "withdrawn": null, "status": "Active", "status_note": null, "derived_from_gudid": true } ], "no_longer_listed_by": [], "certificates": [], "recalls": [ { "number": "Z-1613-2026", "classification": "Class II", "status": "ongoing", "initiated": "2026-02-12", "reason": "The MAJ-1443 and MAJ-1444 are no longer reprocessing compatible with the OER-Pro and OER-Elite automated endoscope reprocessors.", "applies": "this device", "via": "K103264" }, { "number": "Z-0873-2026", "classification": "Class II", "status": "ongoing", "initiated": "2025-10-31", "reason": "Inform existing affected device customers about pertinent Warnings/Cautions, existing recommended maintenance\nschedules and that only properly trained personnel conduct repairs and maintenance.", "applies": "this device", "via": "K103264" }, { "number": "Z-0874-2026", "classification": "Class II", "status": "ongoing", "initiated": "2025-10-31", "reason": "Inform existing affected device customers about pertinent Warnings/Cautions, existing recommended maintenance\nschedules and that only properly trained personnel conduct repairs and maintenance.", "applies": "this device", "via": "K120357" }, { "number": "Z-1009-2024", "classification": "Class II", "status": "ongoing", "initiated": "2024-01-16", "reason": "Water filter may have been assembled incorrectly, resulting in unfiltered tap water being used for reprocessing. This may expose a patient to a potentially contaminated device, presenting a risk of infection or sepsis.", "applies": "this device", "via": "K103264" }, { "number": "Z-2447-2023", "classification": "Class II", "status": "ongoing", "initiated": "2023-07-12", "reason": "The air/water valve MAJ-1444 used with OER-Pro and OER-Elite may become damaged and result in loss of the one-way valve functionality by repeated automated endoscope reprocessing in Olympus OER machines, causing body fluid could backflow into the air/water channel of the ultrasonic endoscopes during the procedure.", "applies": "this device", "via": "K103264" }, { "number": "Z-2342-2023", "classification": "Class II", "status": "ongoing", "initiated": "2023-05-26", "reason": "Revised OER-Pro, OER-Elite, OER-Mini endoscope reprocessor labeling- the LF-V and LF-P are no longer compatible endoscopes for reprocessing in the OERs.\nThe addendum highlights the following changes:\n1. Removal of LF-V and LF-P as compatible with the OER\n2. Change conditions for ETO gas sterilization from 12% EtO to 100% EtO\n3. Removing the reusable cleaning brush for the manual cleaning. Single Use brushes\nremain compatible", "applies": "this device", "via": "K103264" }, { "number": "Z-2343-2023", "classification": "Class II", "status": "ongoing", "initiated": "2023-05-26", "reason": "Revised OER-Pro, OER-Elite, OER-Mini endoscope reprocessor labeling- the LF-V and LF-P are no longer compatible endoscopes for reprocessing in the OERs.\nThe addendum highlights the following changes:\n1. Removal of LF-V and LF-P as compatible with the OER\n2. Change conditions for ETO gas sterilization from 12% EtO to 100% EtO\n3. Removing the reusable cleaning brush for the manual cleaning. Single Use brushes\nremain compatible", "applies": "this device", "via": "K120357" }, { "number": "Z-0138-2017", "classification": "Class II", "status": "terminated", "initiated": "2016-06-23", "reason": "New warning requiring Users to conduct duodenoscope precleaning and manual cleaning even when using an Automated Endoscope Reprocessor (AER) that has instructions that may indicate a user could forego certain steps in precleaning and manual cleaning of the endoscopes.", "applies": "this device", "via": "K103264" } ], "eu_market_availability": null, "properties": [ { "group": "Identity", "fields": [ { "label": "Trade name", "values": [ { "value": "WASHING CASE", "registries": [ "FDA GUDID (AccessGUDID)" ] } ] }, { "label": "Generic name", "values": [ { "value": "Sterilizer/disinfector rack", "registries": [ "FDA GUDID (AccessGUDID)" ] } ] }, { "label": "Model / Ref / Catalog", "values": [ { "value": "MAJ-827", "registries": [ "FDA GUDID (AccessGUDID)" ] }, { "value": "6808900", "registries": [ "FDA GUDID (AccessGUDID)" ] } ] } ] }, { "group": "Identifiers", "fields": [ { "label": "Primary DI / UDI-DI", "values": [ { "value": "04953170069512", "registries": [ "FDA GUDID (AccessGUDID)" ] } ] }, { "label": "FDA product code", "values": [ { "value": "FEB", "registries": [ "FDA GUDID (AccessGUDID)" ] } ] }, { "label": "GMDN term", "values": [ { "value": "Sterilizer/disinfector rack", "code": "62151", "registries": [ "FDA GUDID (AccessGUDID)" ] } ] } ] }, { "group": "Classification", "fields": [ { "label": "Device class", "values": [ { "value": "Class II", "registries": [ "FDA GUDID (AccessGUDID)" ] } ] }, { "label": "Regulation number", "values": [ { "value": "876.1500", "registries": [ "FDA GUDID (AccessGUDID)" ] } ] }, { "label": "GUDID distribution status", "values": [ { "value": "Not in Commercial Distribution", "registries": [ "FDA GUDID (AccessGUDID)" ] } ] } ] }, { "group": "Properties", "fields": [ { "label": "Prescription use", "values": [ { "value": "Yes", "registries": [ "FDA GUDID (AccessGUDID)" ] } ] }, { "label": "Lot / batch number", "values": [ { "value": "Yes", "registries": [ "FDA GUDID (AccessGUDID)" ] } ] }, { "label": "Manufacturing date", "values": [ { "value": "Yes", "registries": [ "FDA GUDID (AccessGUDID)" ] } ] }, { "label": "Supplied sterile", "values": [ { "value": "No", "registries": [ "FDA GUDID (AccessGUDID)" ] } ] }, { "label": "Sterilise before use", "values": [ { "value": "No", "registries": [ "FDA GUDID (AccessGUDID)" ] } ] }, { "label": "Single use", "values": [ { "value": "No", "registries": [ "FDA GUDID (AccessGUDID)" ] } ] }, { "label": "Implantable", "values": [ { "value": "No", "registries": [ "FDA GUDID (AccessGUDID)" ] } ] }, { "label": "Contains latex", "values": [ { "value": "No", "registries": [ "FDA GUDID (AccessGUDID)" ] } ] }, { "label": "Over-the-counter", "values": [ { "value": "No", "registries": [ "FDA GUDID (AccessGUDID)" ] } ] }, { "label": "Convenience kit", "values": [ { "value": "No", "registries": [ "FDA GUDID (AccessGUDID)" ] } ] }, { "label": "Combination product", "values": [ { "value": "No", "registries": [ "FDA GUDID (AccessGUDID)" ] } ] }, { "label": "HCT/P", "values": [ { "value": "No", "registries": [ "FDA GUDID (AccessGUDID)" ] } ] }, { "label": "Premarket exempt", "values": [ { "value": "No", "registries": [ "FDA GUDID (AccessGUDID)" ] } ] }, { "label": "Serial number", "values": [ { "value": "No", "registries": [ "FDA GUDID (AccessGUDID)" ] } ] }, { "label": "Expiration date", "values": [ { "value": "No", "registries": [ "FDA GUDID (AccessGUDID)" ] } ] } ] } ] }