FDA.reportPublic FDA data

Novi Software

Primary DI
00856298006237
Brand
Novi Software
Company
SCOTTCARE CORPORATION, THE
Model
Novi Software
Catalog number
101633
Device description
Software used for the interaction and programming of the Novi Device.
Published
2016-09-19
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
DSHRecorder, Magnetic Tape, Medical

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DSHRecorder, Magnetic Tape, MedicalCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K042463000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K042463000HOLTER PLUSRozinn Electronics, Inc.2004-09-22DQK

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00856298006237PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00856298006237008562980062378562980062370856298006237

GMDN Terms#

Term, Definition table
TermDefinition
Electrocardiographic long-term ambulatory recording analyser application softwareA dedicated application data program designed for use in, or together with, an electrocardiographic long-term ambulatory recording analyser so that this may function according to its intended purpose. This software program can be permanently installed, or exchanged as an upgrade. It may also be produced for installation in an off-the-shelf desktop or laptop computer.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
216-362-0550service@scottcare.com

Regulatory Flags#

DUNS number
808204957
Device count
1
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00856298006411AermosAermos System2025-10-28
00856298006428EZLink-REZLink-R1032012024-05-23
00856298006435EZLink-CEZLink-C1032002024-05-23
00856298006282TeleRehab Receiver BoxTR6201011272016-09-19
00856298006299TeleRehab Receiver CardTeleRehab Receiver Card1000072016-09-19
00856298006114Transtelephonic Receiving ModuleTranstelephonic Receiving Module1001512016-09-19
00856298006046TeleSentry BatteryTS01101109B2017-01-11
00856298006077Telemetry 3 Lead Patient CableTelemetry 3 Lead Patient Cable1002332016-09-19
00856298006084Telemetry 5 Lead Patient CableTelemetry 5 Lead Patient Cable1002342016-09-19
00856298006091Chroma2 5 Lead Patient CableChroma2 5 Lead Patient Cable2016-09-19
00856298006107Chroma2 7 Lead Patient CableChroma2 7 Lead Patient Cable1019282016-09-19
00856298006121TeleSentry 3 Lead Patient CableTeleSentry 3 Lead Patient Cable1001722016-09-19
00856298006138"TeleSense 3 Lead Patient Cable 30""""TeleSense 3 Lead Patient Cable 30"""1018262016-09-19
00856298006145"TeleSense 3 Lead Patient Cable 40""""TeleSense 3 Lead Patient Cable 40"""1018732016-09-19
00856298006275TeleRehab ComputerTeleRehab Computer1018192016-09-19
00856298006008ChromaRZ153C1012732016-09-19
00856298006015Chroma2RZ153C21019422016-09-19
00856298006022TeleSenseRCMMCT17741018382016-09-19
00856298006039TeleSense-EE17741018392016-09-19
00856298006220Chroma 5 Lead Patient Cable1006052017-01-23

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08883000007413AeviceMDAEVICE HEALTH PTE. LTD.DSH2026-05-18
00857522005125myPatch®DMS-SERVICE LLCDSH2026-05-06
00884838129238Care AssistPhilips Medizin Systeme Böblingen GmbHDSH2026-04-17
00884838129245Care AssistPhilips Medizin Systeme Böblingen GmbHDSH2026-04-17
K00010eWave 6-Lead EKGWearlinq, Inc.DSH2026-04-02
P00010eWave Electrode PatchWearlinq, Inc.DSH2026-04-02
00884838129214Care AssistPhilips Medizin Systeme Böblingen GmbHDSH2026-03-09
00884838129221Care AssistPhilips Medizin Systeme Böblingen GmbHDSH2026-03-09
17540279200027CardioSTATIcentia Inc.DSH2025-12-08
00884838127456Care AssistPhilips Medizin Systeme Böblingen GmbHDSH2025-11-17
00884838127463Care AssistPhilips Medizin Systeme Böblingen GmbHDSH2025-11-17
08800069700260AT-PatchATsens Co., Ltd.DSH2025-11-05
08800069700277AT-PatchATsens Co., Ltd.DSH2025-11-05
00884838127432Care AssistPhilips Medizin Systeme Böblingen GmbHDSH2025-05-06
00884838127449Care AssistPhilips Medizin Systeme Böblingen GmbHDSH2025-05-06
27540279250029CardioSTATIcentia Inc.DSH2024-12-18
27540279250074CardioSTATIcentia Inc.DSH2024-12-18
27540279250142CardioSTATIcentia Inc.DSH2024-12-18
00884838123717Care AssistPhilips Medical Systems HsgDSH2024-11-27
00884838123724Care AssistPhilips Medical Systems HsgDSH2024-11-27
00860007323409Vitals360Vocare, Inc.DSH2024-09-10
B146EP25R0ePatch Sensor 2.5, RebuiltBRAEMAR MANUFACTURING, LLCDSH2024-06-26
04250413405640ABPM pro basic deviceSOMNOmedics AGDSH2024-05-08
00815187020112Matrix WearableGLOBAL INSTRUMENTATION, LLCDSH2024-04-01
00815187020440Matrix WearableGLOBAL INSTRUMENTATION, LLCDSH2024-04-01
00815187020457Matrix WearableGLOBAL INSTRUMENTATION, LLCDSH2024-04-01
00815187020587Matrix WearableGLOBAL INSTRUMENTATION, LLCDSH2024-04-01
00815187020594Matrix WearableGLOBAL INSTRUMENTATION, LLCDSH2024-04-01
17540279105018EARTIcentia Inc.DSH2024-03-26
17540279200072CardioSTATIcentia Inc.DSH2024-03-26