FDA.reportPublic FDA data

SafeID

Primary DI
05056190500658
Brand
SafeID
Company
VISION RT LIMITED
Model
SafeID 2.0
Device description
SafeID 2.0
Published
2025-12-23
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
OUGMedical Device Data System

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OUGMedical Device Data SystemGeneral Hospital1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05056190500658PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05056190500658050561905006585056190500658

GMDN Terms#

Term, Definition table
TermDefinition
Patient-administration information system application softwareAn application software program, routines, and/or algorithms intended to be used as or in an information system to electronically receive, collect, store, manage, assist in analysis of, display, output, and distribute data, within or between healthcare facilities, to support patient administration services. Data typically include patient demographic information with patient admission, discharge, transfer, and outpatient-contact information. The device is available for installation into existing mainframe or decentralized computers/networks.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
222160801
Device count
1
Premarket exempt
true
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
05056190501365AlignRTGATECT-RT 1.02026-04-27
05056190500009AlignRTAlignRT 5.x 115V or 230V2021-09-23
05056190500924MapRTMapRT system2025-12-23
05056190500931AlignRT PlusHorizon camera (close range)2025-12-23
05056190501037AlignRT PlusReal Time Coach MK22025-12-23
05056190501044MapRTMapRT Mapping application (v1.2)2025-12-23
05056190501051MapRTMapRT Capture (v1.2)2025-12-23
05056190501068AlignRT PlusInBore Fibre Hub2025-12-23
05056190501099MapRTMapRT couch markers2025-12-23
05056190501112AlignRT PlusHP Z2 G9 workstation - AlignRT2025-12-23
05056190501129AlignRT PlusHP Z2 G9 workstation - AlignRT InBore2025-12-23
05056190501150AlignRT PlusDoseRT (software phase 2)2025-12-23
05056190501167AlignRT PlusAlignRT 7.4 2025-12-23
05056190501174AlignRT PlusDoseRT (software)2025-12-23
05056190501204AlignRT PlusInBore Patient Imaging Assembly2025-12-23
05056190501242AlignRT PlusDoseRT workstation2025-12-23
05056190501259AlignRT PlusDoseRT camera-computer interface box2025-12-23
05056190501266AlignRT PlusDoseRT isolation transformer2025-12-23
05056190501273MapRTHP Z2 G9 workstation - MapRT2025-12-23
05056190501280AlignRT PlusMevion Interface Unit2025-12-23

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04048675544227Connectivity Converter CC300Drägerwerk AG & Co. KGaAOUG2026-07-17
04260658860258myoncareONCARE GmbHOUG2026-07-17
00840241600443Kestra Provided Device Patient ApplicationKestra Medical Technologies, Inc.OUG2026-07-16
00884400004871GoClinicMonitored Therapeutics, Inc.OUG2026-07-16
00884400085481GoMobileMonitored Therapeutics, Inc.OUG2026-07-16
04035479194192PatientApp 2.10.0BIOTRONIK SE & Co. KGOUG2026-07-16
00884838132337Care AssistPhilips Medizin Systeme Böblingen GmbHOUG2026-07-13
00884838132344Care AssistPhilips Medizin Systeme Böblingen GmbHOUG2026-07-13
04048675558552Vista GatewayShanghai Draeger Medical Instrument Co.,Ltd.OUG2026-07-13
04048675558569Vista GatewayShanghai Draeger Medical Instrument Co.,Ltd.OUG2026-07-13
04048675558576Vista GatewayShanghai Draeger Medical Instrument Co.,Ltd.OUG2026-07-13
04048675663997Vista GatewayShanghai Draeger Medical Instrument Co.,Ltd.OUG2026-07-13
00199150006038N/AMEDTRONIC, INC.OUG2026-05-23
04931921049464NANIHON KOHDEN CORPORATIONOUG2026-05-20
04931921111697NANIHON KOHDEN CORPORATIONOUG2026-05-20
00199150021277NAMEDTRONIC, INC.OUG2026-05-02
00199150042784NAMEDTRONIC, INC.OUG2026-04-30
00199874112060CliniSphereMonitored Therapeutics, Inc.OUG2026-04-28
00850022853036ProSomnus RPMO2 OSA DevicePROSOMNUS SLEEP TECHNOLOGIESOUG2026-04-24
00884838129238Care AssistPhilips Medizin Systeme Böblingen GmbHOUG2026-04-17
00884838129245Care AssistPhilips Medizin Systeme Böblingen GmbHOUG2026-04-17
00199150002191N/AMEDTRONIC, INC.OUG2026-04-02
05404028001158Mimics FlowMaterialise NVOUG2026-03-23
05404028001172SurgiCase OnlineMaterialise NVOUG2026-03-23
05404028001189ProPlan CMF Materialise NVOUG2026-03-23
00763000994914NAMEDTRONIC, INC.OUG2026-03-22
00382904450106BD Veritor™ InfoWiFi ModuleBECTON, DICKINSON AND COMPANYOUG2026-03-13
00884838129214Care AssistPhilips Medizin Systeme Böblingen GmbHOUG2026-03-09
00884838129221Care AssistPhilips Medizin Systeme Böblingen GmbHOUG2026-03-09
04035479189211PatientApp 2.9BIOTRONIK SE & Co. KGOUG2026-03-04