{ "format": "devicerts.device.v1", "cite_as": "Luer Lock Set, Single Lumen LL0002, Thermedx, LLC. deviCERTS medical device catalogue. https://devicerts.com/devices/luer-lock-set-single-lumen-ll0002 (data as of 2026-11-14).", "source": { "canonical_url": "https://devicerts.com/devices/luer-lock-set-single-lumen-ll0002", "json_url": "https://devicerts.com/devices/luer-lock-set-single-lumen-ll0002.json", "markdown_url": "https://devicerts.com/devices/luer-lock-set-single-lumen-ll0002.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": "2026-10-22", "status_as_of": "2026-11-14", "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/luer-lock-set-single-lumen-ll0002", "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": "Luer Lock Set, Single Lumen LL0002", "registry_name": "Luer Lock Set, Single Lumen LL0002", "url": "https://devicerts.com/devices/luer-lock-set-single-lumen-ll0002", "manufacturer": { "name": "Thermedx, LLC", "url": "https://devicerts.com/manufacturers/thermedx-llc", "country": "United States", "country_basis": "FDA 510(k) applicant", "fda_registration_country": null }, "status": { "state": "active", "label": "Active", "detail": "United States" }, "classification": [ { "class": "Class II", "system": "US FDA" } ], "identifiers": [ { "label": "Primary DI / UDI-DI", "values": [ { "value": "00860936000334", "registries": [ "FDA GUDID (AccessGUDID)" ] } ] }, { "label": "510(k) Number", "values": [ { "value": "K091939", "registries": [ "FDA GUDID (AccessGUDID)" ] }, { "value": "K133799", "registries": [ "FDA GUDID (AccessGUDID)" ] } ] } ], "product_codes": [ "HRX", "LGZ", "HIG" ], "emdn": [], "gmdn": [ { "code": "36122", "term": "Hysteroscopic irrigation/insufflation system" } ], "description": null, "noindex": true }, "authorizations": [ { "registry": "GUDID", "region": "United States", "type": "GUDID listing", "number": "00860936000334", "number_label": "UDI-DI", "device_udi_di": null, "date": "2016-09-23", "date_kind": "listed", "decision_code": null, "expires": null, "withdrawn": null, "status": "Listed", "status_note": "GUDID: in commercial distribution", "derived_from_gudid": false }, { "registry": "GUDID", "region": "United States", "type": "FDA 510(k)", "number": "K133799", "number_label": null, "device_udi_di": null, "date": "2014-06-20", "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": "K091939", "number_label": null, "device_udi_di": null, "date": "2010-07-23", "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-1463-2015", "classification": "Class II", "status": "terminated", "initiated": "2014-09-01", "reason": "To correct software bugs that could affect the ability to accurately measure fluid deficit.", "applies": "this device", "via": "K091939" }, { "number": "Z-2555-2014", "classification": "Class II", "status": "terminated", "initiated": "2014-02-10", "reason": "A vendor changed the manufacturing process of a component used in the canister ring that may affect the performance of the ring. The deficit display may be higher than the actual deficit when the fluid collection canister is fully loaded.", "applies": "shared submission", "via": "K091939" } ], "eu_market_availability": null, "properties": [ { "group": "Identity", "fields": [ { "label": "Trade name", "values": [ { "value": "Luer Lock Set, Single Lumen", "registries": [ "FDA GUDID (AccessGUDID)" ] } ] }, { "label": "Generic name", "values": [ { "value": "Hysteroscopic irrigation/insufflation system", "registries": [ "FDA GUDID (AccessGUDID)" ] } ] }, { "label": "Model / reference", "values": [ { "value": "LL0002", "registries": [ "FDA GUDID (AccessGUDID)" ] } ] } ] }, { "group": "Identifiers", "fields": [ { "label": "Primary DI / UDI-DI", "values": [ { "value": "00860936000334", "registries": [ "FDA GUDID (AccessGUDID)" ] } ] }, { "label": "510(k) Number", "values": [ { "value": "K091939", "registries": [ "FDA GUDID (AccessGUDID)" ] }, { "value": "K133799", "registries": [ "FDA GUDID (AccessGUDID)" ] } ] }, { "label": "FDA product code", "values": [ { "value": "HRX", "registries": [ "FDA GUDID (AccessGUDID)" ] }, { "value": "LGZ", "registries": [ "FDA GUDID (AccessGUDID)" ] }, { "value": "HIG", "registries": [ "FDA GUDID (AccessGUDID)" ] } ] }, { "label": "GMDN term", "values": [ { "value": "Hysteroscopic irrigation/insufflation system", "code": "36122", "registries": [ "FDA GUDID (AccessGUDID)" ] } ] } ] }, { "group": "Classification", "fields": [ { "label": "Device class", "values": [ { "value": "Class II", "registries": [ "FDA GUDID (AccessGUDID)" ] } ] }, { "label": "Regulation number", "values": [ { "value": "888.1100", "registries": [ "FDA GUDID (AccessGUDID)" ] }, { "value": "880.5725", "registries": [ "FDA GUDID (AccessGUDID)" ] }, { "value": "884.1700", "registries": [ "FDA GUDID (AccessGUDID)" ] } ] }, { "label": "GUDID distribution status", "values": [ { "value": "In Commercial Distribution", "registries": [ "FDA GUDID (AccessGUDID)" ] } ] } ] }, { "group": "Clinical & Handling", "fields": [ { "label": "MRI safety", "values": [ { "value": "MR Unsafe", "registries": [ "FDA GUDID (AccessGUDID)" ] } ] } ] }, { "group": "Dimensions & Sizes", "fields": [ { "label": "Size", "values": [ { "value": "Pressure — 250 millibar", "registries": [ "FDA GUDID (AccessGUDID)" ] } ] } ] }, { "group": "Properties", "fields": [ { "label": "Supplied sterile", "values": [ { "value": "Yes", "registries": [ "FDA GUDID (AccessGUDID)" ] } ] }, { "label": "Single use", "values": [ { "value": "Yes", "registries": [ "FDA GUDID (AccessGUDID)" ] } ] }, { "label": "Prescription use", "values": [ { "value": "Yes", "registries": [ "FDA GUDID (AccessGUDID)" ] } ] }, { "label": "Lot / batch number", "values": [ { "value": "Yes", "registries": [ "FDA GUDID (AccessGUDID)" ] } ] }, { "label": "Expiration date", "values": [ { "value": "Yes", "registries": [ "FDA GUDID (AccessGUDID)" ] } ] }, { "label": "Manufacturing date", "values": [ { "value": "Yes", "registries": [ "FDA GUDID (AccessGUDID)" ] } ] }, { "label": "Sterilise before 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)" ] } ] } ] } ] }