FDA.reportPublic FDA data

Amimon

Primary DI
00860014100635
Brand
Amimon
Company
Rocoto Inc.
Model
MD11 Rx device - MDWL1_B1N1RX
Catalog number
MDWL1_B1N1RX
Device description
MD11 Rx device
Published
2025-06-24
Public version status
Update
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
00860014100635PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00860014100635008600141006358600141006350860014100635

GMDN Terms#

Term, Definition table
TermDefinition
Medical image management systemA computerized image data management system designed to electronically receive, collect, store, and display a broad range of medical imaging/video data (non-dedicated), and to distribute the data within or between healthcare facilities to facilitate data analysis, organization, reporting, and sharing (e.g., teaching). The system consists of combined hardware (e.g., network switch, controller) and server/client software intended to relay image data from a broad range of imaging/audiovisual devices (e.g., endoscopic camera, ultrasound imaging system, radiography digital imaging system) to off-the-shelf devices [e.g., monitors, personal computers (PC’s)].

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
960475866
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
00860015454706RocotoMD62 Tx Device - MDWL2_B1J1TX2026-02-26
00860015454713RocotoMD62 Rx Device - MDWL2_B1J1RX2026-02-26
00860015454720RocotoMD11 Tx device - MDWL1_C1N1TX2026-02-26
00860015454737RocotoMD11 Rx device - MDWL1_B1J1RX2026-02-26
00860015454744RocotoSL11 device - Wireless Camera - MDMP1_SL11_1STE122026-02-26
00860015454751RocotoSL11 device Sterilizable Cover - AMN_ASM_10302026-02-26
00860015454768RocotoMD52 Tx - MDWL2_B1P1TX2026-02-26
00860015454775RocotoMD52 Rx - MDWL2_B3P1RX2026-02-26
00860015454782RocotoHM11 Device - MDWL1_HM112026-02-26
00860014100604AmimonMD62 Tx device - MDWL2_B1J1TXMDWL2_B1J1TX2025-06-24
00860014100611AmimonMD62 Rx device - MDWL2_B1J1RX MDWL2_B1J1RX2025-06-24
00860014100628AmimonMD11 Tx device - MDWL1_C1N1TXMDWL1_C1N1TX2025-06-24
00860014100642AmimonSL11 device - Wireless Camera - MDMP1_SL11_1STE12MDMP1_SL11_1STE122025-06-24
00860014100659AmimonSL11 Sterilizable Cover - AMN_ASM_1030AMN_ASM_10302025-06-24
00860014100666AmimonMD52 Tx device - MDWL2_B1P1TXMDWL2_B1P1TX2025-06-24
00860014100673AmimonMD52 Rx device - MDWL2_B3P1RXMDWL2_B3P1RX2025-06-24
00860014100680AmimonHM11 Device - MDWL1_HM11MDWL1_HM112025-06-24

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