FDA.reportPublic FDA data

HOLTER CONNECT

Primary DI
B353LA1252C1
Brand
HOLTER CONNECT
Company
Lifesignals, Inc.
Model
LA1252C
Device description
HOLTER CONNECT business logic is a software running on cloud platform that provides interface for technician to generate Holter report on ECG data of patient, provides interface for physician to access and e-sign the Holter Report generated by the ECG technician.
Published
2021-11-15
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
DRGTransmitters And Receivers, Physiological Signal, Radiofrequency
MWJElectrocardiograph, Ambulatory (Without Analysis)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DRGTransmitters And Receivers, Physiological Signal, RadiofrequencyCardiovascular2
MWJElectrocardiograph, Ambulatory (Without Analysis)Cardiovascular2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B353LA1252C1PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Patient health record 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 electronic registration and documentation of patient clinical data. It typically enables healthcare providers to review and update patient medical records, place orders (e.g., for medications, procedures, tests), and sometimes view multimedia data from many specialties. It is supplied for installation into a dedicated information system for patient health records, or existing mainframe or decentralized computers/networks.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
510.770.6412lssupport@lifesignals.com

Regulatory Flags#

DUNS number
798830720
Device count
1
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
B353CV12531CorVitalsCV1253CV1253_US2021-05-14
B353UB12511UbiqVue HolterUB12512025-04-22
B353UB22511UbiqVue HolterUB22512025-04-22
B353UA2251C1UbiqVue UA2251-C2025-04-22
B353UA2251DA1UbiqVue UA2251-DA2025-04-22
B353UA2251R1UbiqVue UA2251-R2025-04-22
B353UA2251S1UbiqVue UA2251-S2025-04-22
B353UA2251SA1UbiqVue UA2251-SA2025-04-22
B353UA2251W1UbiqVue UA2251-W2025-04-22
B353UB12512UbiqVue HolterUB12512025-04-22
B353UB22512UbiqVue HolterUB22512025-04-22
B353UB25501UbiqVue MultiparameterUB25502024-11-29
B353UB25502UbiqVue MultiparameterUB25502024-11-29
B353UA2550BG1UbiqVue UA2550-BG2024-05-15
B353UA2550C1UbiqVue UA2550-C2024-05-15
B353UA2550MR1UbiqVue UA2550-MR2024-05-15
B353UA2550RB1UbiqVue UA2550-RB2024-05-15
B353UA2550S1UbiqVue UA2550-S2024-05-15
B353UA2550R1UbiqVue UA2550-R2024-05-06
B353UB15501UbiqVue MultiparameterUB15502024-05-06

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Primary DI, Brand, Company table
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B3945700048100WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.DRG2026-05-27
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B3945700064010WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.DRG2026-05-27
B3945700068020WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.DRG2026-05-27
10841522131349Eclipse ProSPACELABS HEALTHCARE (WASHINGTON), INCMWJ2025-10-09
10841522131356Eclipse ProSPACELABS HEALTHCARE (WASHINGTON), INCMWJ2025-10-09
10841522131363Eclipse ProSPACELABS HEALTHCARE (WASHINGTON), INCMWJ2025-10-09
10841522131387Eclipse ProSPACELABS HEALTHCARE (WASHINGTON), INCMWJ2025-10-09
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10841522131370Eclipse ProSPACELABS HEALTHCARE (WASHINGTON), INCMWJ2025-10-01
B353UB12511UbiqVue HolterLifesignals, Inc.MWJ2025-04-22
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