Novi Software 101633

GUDID 00856298006237

Software used for the interaction and programming of the Novi Device.

SCOTTCARE CORPORATION, THE

Electrocardiographic long-term ambulatory recording analyser application software
Primary Device ID00856298006237
NIH Device Record Key7817eb50-462c-46a0-aa91-e8a6a5f7a4d2
Commercial Distribution StatusIn Commercial Distribution
Brand NameNovi Software
Version Model NumberNovi Software
Catalog Number101633
Company DUNS808204957
Company NameSCOTTCARE CORPORATION, THE
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Customer Support Contacts

Phone216-362-0550
Emailservice@scottcare.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100856298006237 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

DSHRecorder, Magnetic Tape, Medical

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2016-09-19

Devices Manufactured by SCOTTCARE CORPORATION, THE

00856298006428 - EZLink-R2024-05-31
00856298006435 - EZLink-C2024-05-31
00856298006008 - Chroma2019-11-08 The Chroma model RZ153C Holter monitor is a battery operated solid-state recorder. It is designed for up to 48 hours (2 days) co
00856298006015 - Chroma22019-11-08
00856298006022 - TeleSenseRCM2019-11-08 The TeleSense device is intended for diagnostic evaluation of patients who experience transient symptoms or asymptomatic events
00856298006039 - TeleSense-E2019-11-08 The TeleSense device is intended for diagnostic evaluation of patients who experience transient symptoms or asymptomatic events
00856298006220 - Chroma 5 Lead Patient Cable2019-11-08 5 lead ECG patient cable to be used with the Chroma device.
00856298006312 - Chroma 7 Lead Patient Cable2019-11-08 7 lead ECG patient cable to be used with the Chroma device.

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