FDA.reportPublic FDA data

Clear Arch Mobile

Primary DI
00817644020185
Brand
Clear Arch Mobile
Company
Mobilehelp, LLC
Model
1
Device description
Remote Patient Monitoring Application
Published
2022-11-21
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

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
00817644020185PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00817644020185008176440201858176440201850817644020185

GMDN Terms#

Term, Definition table
TermDefinition
Home healthcare information system application softwareAn application software program, routines, and/or algorithms 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 the administrative and clinical activities associated with the provision and utilization of home healthcare services and facilities. It is typically supplied for installation into a dedicated home healthcare information system or existing mainframe or decentralized computers/networks.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
023260604
Device count
1
Premarket exempt
true
Serial number
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00817644020161Genesis Touch Tab A 8.4 - RCT6055526B12021-03-31
00817644020178Genesis Touch Tab A 8.46055523B12020-06-23
00817644020154Genesis Touch TAB E ATT6055325A12019-05-14
00817644020000LifeStream Application42016-09-22
00817644020017Genesis Touch TAB E6055223B12016-09-22
00817644020024Genesis Touch Application32016-09-22
00817644020031Genesis Touch TAB 46055123B12016-09-22
00817644020048Genesis DM Pro BP6053000A12016-09-22
00817644020055Genesis Touch TAB 26055023B12016-09-22
00817644020079LifeStream Application52017-06-05
00817644020086Genesis DM w ST NIBP 16050000RE12017-10-26
00817644020093Genesis DM2 w ST NIBP6052000RE12017-10-26
00817644020109Genesis DM2 w OM NIBP6052001RE12017-10-26
00817644020116Genesis DM w ST NIBP 26053000RE12017-10-26
00817644020123Genesis DM w OM NIBP6053001RE12017-10-26
00817644020130Genesis Touch Tab E 32 GB6055323B12018-06-22
00817644020147Genesis Touch Tab A6055423B12018-12-03

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
07350149360033PD Care SystemPainDrainer ABOUG2026-03-04
00860015454706RocotoRocoto Inc.OUG2026-02-26
00860015454713RocotoRocoto Inc.OUG2026-02-26
00860015454720RocotoRocoto Inc.OUG2026-02-26
00860015454737RocotoRocoto Inc.OUG2026-02-26
00860015454768RocotoRocoto Inc.OUG2026-02-26
00860015454775RocotoRocoto Inc.OUG2026-02-26
00840241600412Kestra Provided Device Patient ApplicationKestra Medical Technologies, Inc.OUG2026-02-04
00199150002184NAMEDTRONIC, INC.OUG2026-02-01
03770034761006LIMSTARHOPI MEDICALOUG2026-01-28
03770034761013MINILIMHOPI MEDICALOUG2026-01-28
03770034761020FMCHOPI MEDICALOUG2026-01-28