FDA.reportPublic FDA data

Genesis DM2 w ST NIBP

Primary DI
00817644020093
Brand
Genesis DM2 w ST NIBP
Company
Mobilehelp, LLC
Model
6052000RE1
Published
2017-10-26
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
DRGTransmitters And Receivers, Physiological Signal, Radiofrequency

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DRGTransmitters And Receivers, Physiological Signal, RadiofrequencyCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K061087000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K061087000GENESIS OTC MONITORHoneywell Hommed, LLC2006-06-09DRG

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00817644020093PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00817644020093008176440200938176440200930817644020093

GMDN Terms#

Term, Definition table
TermDefinition
Home healthcare information systemA dedicated assembly of devices designed 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. The system consists of dedicated combined hardware (e.g., computers, terminals, network components) and software (typically embedded).

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
023260604
Device count
1
Serial number
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
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
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
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04719875011016EZYPRO ECG RecorderSIGKNOW BIOMEDICAL CO., LTD.DRG2026-06-01
04719875011023EZYPRO ECG RecorderSIGKNOW BIOMEDICAL CO., LTD.DRG2026-06-01
04719875011030EZYPRO ECG RecorderSIGKNOW BIOMEDICAL CO., LTD.DRG2026-06-01
B3944060056010WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.DRG2026-05-27
B3944670047010WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.DRG2026-05-27
B3945000030010WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.DRG2026-05-27
B3945300046010WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.DRG2026-05-27
B3945300054010WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.DRG2026-05-27
B3945300054020WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.DRG2026-05-27
B3945600013020WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.DRG2026-05-27
B3945700048010WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.DRG2026-05-27
B3945700048020WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.DRG2026-05-27
B3945700048030WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.DRG2026-05-27
B3945700048040WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.DRG2026-05-27
B3945700048050WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.DRG2026-05-27
B3945700048060WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.DRG2026-05-27
B3945700048070WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.DRG2026-05-27
B3945700048080WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.DRG2026-05-27
B3945700048090WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.DRG2026-05-27
B3945700048100WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.DRG2026-05-27
B3945700051020WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.DRG2026-05-27
B3945700063010WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.DRG2026-05-27
B3945700064010WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.DRG2026-05-27
B3945700068020WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.DRG2026-05-27
00195278990914Portrait CSSXBGe Medical Systems Information Technologies, Inc.DRG2025-12-10
00198953024096Portrait CVAXBGe Medical Systems Information Technologies, Inc.DRG2025-12-10
00198953030981PORTRAIT HSWXBGE Healthcare Finland OyDRG2025-12-10
B353UB12511UbiqVue HolterLifesignals, Inc.DRG2025-04-22
B353UB22511UbiqVue HolterLifesignals, Inc.DRG2025-04-22