FDA.reportPublic FDA data

Clinical laboratory information system

Definition
A dedicated assembly of devices designed to electronically receive, collect, store, display, output and distribute clinical laboratory information (e.g., transfer of digital images), within or between healthcare facilities, to support the administrative and clinical activities associated with clinical laboratory services and facilities. Some systems will also assist in data management/analysis. The system consists of dedicated combined hardware (e.g., computers, terminals, network components) and software (typically embedded, and not directly used to run, steer, or control laboratory analysers or equipment).
GUDID devices
64
Last updated
2026-06-04 19:44:10

Representative GUDID Devices#

Primary DI, Brand, Company table
Primary DIBrandCompanyModelPublished
08885013950045Sentosa SQ301 SequencerVELA OPERATIONS SINGAPORE PTE. LTD.74682016-09-22
08885013950069Sentosa ST401iVELA OPERATIONS SINGAPORE PTE. LTD.4001242017-03-28
08885013950076Sentosa ST401eVELA OPERATIONS SINGAPORE PTE. LTD.4001202016-10-19
03610230008966Yumizen P8000HORIBA ABX SAS13000333272025-07-07
00664369000752WAM (Work Area Management)Sysmex America, Inc.5.X2025-03-14
04987562488506UDM (Urinalysis Data Manager)SYSMEX CORPORATION1.X2025-03-14
06438147366804EVOYA PlatformWallac Oy5021-10002022-11-29
00606959061132DreamStationRespironics, Inc.DreamStation Spo2 Connection Module2020-10-15
00606959058828DreamStationRespironics, Inc.002020-05-20
00606959036550Bluetooth AccessoryRespironics, Inc.002019-02-28
00606959058200DreamStationRespironics, Inc.002019-12-29
00606959058224DreamStationRespironics, Inc.002019-12-29
00606959058859DreamStationRespironics, Inc.002019-12-29
00606959058873DreamStationRespironics, Inc.002019-12-29
00606959058804DreamStationRespironics, Inc.002020-03-30
00606959058170DreamStationRespironics, Inc.012019-11-18
00606959058187DreamStationRespironics, Inc.002019-11-18
00606959050754System OneRespironics, Inc.100240B2019-04-18
00606959021501OmniLab ConnectRespironics, Inc.OmniLab Connect System2019-04-05
06438147153275PatientCareWallac Oy5002-01302019-02-25
06438147153312Specimen Gate LaboratoryWallac Oy5002-01802019-03-19
06438147320905Screening CenterWallac Oy5002-05002019-02-25
06438147352401MSMS WorkstationWallac Oy5002-05402018-11-28
00606959023871DreamStationRespironics, Inc.DreamStation Cellular Modem, US2016-05-16
00606959026674PRI Cellular ModemRespironics, Inc.PRI Cellular Modem, US2016-06-30
00606959026681PRI Cellular ModemRespironics, Inc.PRI Cellular Modem with PRI Label, EU2016-06-30
00606959026698PRI Cellular ModemRespironics, Inc.PRI Cellular Modem, EU2016-06-30
00606959026704PRI Cellular ModemRespironics, Inc.PRI Cellular Modem, JA2016-06-30
00606959028180BroadbandRespironics, Inc.Broadband/Oximetry Accessory, US2016-08-19
00606959028197Broadband ModemRespironics, Inc.Broadband/Oximetry Accessory, JP2016-08-19
00606959028234BroadbandRespironics, Inc.Broadband Ethernet Adapter2016-08-19
00606959028241BroadbandRespironics, Inc.Broadband Modem, RoHS, EU2016-08-19
00606959028616Broadband ModemRespironics, Inc.Oximetry Accessory, EU2016-08-19
00606959033221BroadbandRespironics, Inc.Broadband Modem2016-09-19
00606959033252BroadbandRespironics, Inc.Broadband Modem, EU2016-08-19
00606959033269BroadbandRespironics, Inc.Broadband Modem, APAC2016-08-19
00606959036567Bluetooth Accessory ModuleRespironics, Inc.002016-09-13
00606959038967SleepwareRespironics, Inc.3.12016-09-18
00606959039049HL7 Respironics, Inc.Software, HL7 Forwarding Service - 32016-09-18
00606959040403PRI Cellular Modem, Australia, CanadaRespironics, Inc.PRI Cellular Modem, AU, CA2016-09-19
00606959040465DreamStationRespironics, Inc.DreamStation Nonin SpO2 Cable2017-02-27
00606959043176Nurse callRespironics, Inc."RJ9 to 1/4"" Nurse Call Cable Alarm - Closed"2017-05-02
00606959043183Nurse callRespironics, Inc."RJ9 to 1/4"" Nurse Call Cable Alarm - Open"2017-05-02
00606959043190TrilogyRespironics, Inc.RJ9 Nurse Call Cable - Open End2017-05-02
00606959043244TrilogyRespironics, Inc."RJ9 to 2.5mm 3"" Female Adapter Cable"2017-05-02
00606959043268TrilogyRespironics, Inc.002017-07-18
00606959043466OmniLab ConnectRespironics, Inc.OmniLab Connect System, BR2017-09-13
00606959044258EverFlo ConnectRespironics, Inc.EverFlo Connect Module, US2018-07-13
00606959045835DreamStationRespironics, Inc.DreamStation Cellular Modem with Oximetry, US2017-02-15
00606959045842DreamStationRespironics, Inc.DreamStation Cellular Modem with Oximetry, EU2017-02-15
00606959045859DreamStationRespironics, Inc.DreamStation Wi-Fi Accessory with Oximetry, US2017-02-15
00606959045866DreamStationRespironics, Inc.DreamStation Wi-Fi Accessory with Oximetry, EU2017-02-15
00606959045873DreamStationRespironics, Inc.DreamStation Wi-Fi Accessory with Oximetry, AU2017-02-21
00606959048942HL7Respironics, Inc.Software, HL7 Sleepware G3, Web - 32017-08-30
00606959048973DreamStationRespironics, Inc.DreamStation Cellular Modem with Oximetry, JP2017-12-20
00606959049000DreamStationRespironics, Inc.Cellular Modem, US2017-12-20
00381933771015PTS Connect™ Universal SolutionPOLYMER TECHNOLOGY SYSTEMS, INC.37712016-07-15
00606959005129BluetoothRespironics, Inc.Bluetooth Accessory Module, US2016-09-13
00606959005136BluetoothRespironics, Inc.Bluetooth Accessory Module, CA2016-09-13
00606959005143BluetoothRespironics, Inc.Bluetooth Accessory Module, INTL2016-09-13
00606959013971BroadbandRespironics, Inc.Broadband Accessory and WiFi Router, US2016-08-19
00606959021570BroadbandRespironics, Inc.Broadband/Oximetry Accessory, Intl2016-08-19
00606959022881DreamStationRespironics, Inc.002016-09-13
00606959022942DreamStationRespironics, Inc.DreamStation Cellular Modem with Oximetry, US2016-05-16