FDA.reportPublic FDA data

LifeStream Application

Primary DI
00817644020000
Brand
LifeStream Application
Company
Mobilehelp, LLC
Model
4
Published
2016-09-22
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
DXNSystem, Measurement, Blood-Pressure, Non-Invasive

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DXNSystem, Measurement, Blood-Pressure, Non-InvasiveCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K072272000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K072272000HONEYWELL HOMMED CENTRAL STATION 4.0Honeywell Hommed, LLC2007-09-07DXN

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00817644020000PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00817644020000008176440200008176440200000817644020000

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
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00817644020185Clear Arch Mobile12022-11-21
00817644020161Genesis Touch Tab A 8.4 - RCT6055526B12021-03-31
00817644020178Genesis Touch Tab A 8.46055523B12020-06-23
00817644020154Genesis Touch TAB E ATT6055325A12019-05-14
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
04250413405657ABPMpro SoftwareSOMNOmedics AGDXN2026-10-07
10884450480615Safedraw™ARGON CRITICAL CARE SYSTEMS SINGAPORE PTE. LTD.DXN2026-10-07
00634782102357ADView® 2.6AMERICAN DIAGNOSTIC CORPDXN2026-10-06
00198953009567Carescape ONEGE Healthcare Finland OyDXN2026-10-04
00810226060166Easy@Home Blood Pressure MonitorEASY HEALTHCARE CORPORATIONDXN2026-09-30
06948423816218Electronic Blood Pressure MonitorShenzhen Pango Electronic Co., Ltd.DXN2026-09-30
00093764604737A&D MedicalA&D COMPANY, LIMITEDDXN2026-09-25
00093764604744A&D MedicalA&D COMPANY, LIMITEDDXN2026-09-25
06953825911874AlphaMedShenzhen Urion Technology Co., LtdDXN2026-09-22
06953825911850sakerplusShenzhen Urion Technology Co., LtdDXN2026-09-18
06920485308580P PANACAREShenzhen BSX Technology Electronics Co., Ltd.DXN2026-08-26
06944413835153Telemetry MonitorEdan Instruments, Inc.DXN2026-08-26
06944413835214Telemetry MonitorEdan Instruments, Inc.DXN2026-08-26
00634782102265Advantage™AMERICAN DIAGNOSTIC CORPDXN2026-08-25
00810226442306ViveVIVE HEALTH LLCDXN2026-08-25
00856324008778PARAMEDSILEX GLOBAL LLCDXN2026-08-22
06971522821753LineshareShenzhen Finicare Co., LtdDXN2026-08-22
06971522821760LineshareShenzhen Finicare Co., LtdDXN2026-08-22
06953825911805FOCUSED ADULT ADHD CLINICShenzhen Urion Technology Co., LtdDXN2026-08-19
09120073932778CNAP® ArmslingCNSystems Medizintechnik GmbHDXN2026-08-18
09120073932785CNAP® double finger cuff "small"CNSystems Medizintechnik GmbHDXN2026-08-18
09120073932792CNAP® double finger cuff "medium"CNSystems Medizintechnik GmbHDXN2026-08-18
09120073932808CNAP® double finger cuff "large"CNSystems Medizintechnik GmbHDXN2026-08-18
09120073932815CNAP® double finger cuff "small"CNSystems Medizintechnik GmbHDXN2026-08-18
09120073932822CNAP® double finger cuff "medium"CNSystems Medizintechnik GmbHDXN2026-08-18
09120073932839CNAP® double finger cuff "large"CNSystems Medizintechnik GmbHDXN2026-08-18
09120073932846CNAP® double finger cuff "small"CNSystems Medizintechnik GmbHDXN2026-08-18
09120073932853CNAP® double finger cuff "medium"CNSystems Medizintechnik GmbHDXN2026-08-18
09120073932860CNAP® double finger cuff "large"CNSystems Medizintechnik GmbHDXN2026-08-18
09120073932877CNAP® double finger cuff "small"CNSystems Medizintechnik GmbHDXN2026-08-18