EZLink-C 103200

GUDID 00856298006435

SCOTTCARE CORPORATION, THE

Cardiology information system application software Cardiology information system application software Cardiology information system application software Cardiology information system application software Cardiology information system application software Cardiology information system application software Cardiology information system application software Cardiology information system application software Cardiology information system application software Cardiology information system application software Cardiology information system application software Cardiology information system application software Cardiology information system application software Cardiology information system application software Cardiology information system application software Cardiology information system application software
Primary Device ID00856298006435
NIH Device Record Key4bf3c307-f344-425a-a921-b3bd6babb461
Commercial Distribution StatusIn Commercial Distribution
Brand NameEZLink-C
Version Model NumberEZLink-C
Catalog Number103200
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
Phone216-362-0550
Emailservice@scottcare.com
Phone216-362-0550
Emailservice@scottcare.com
Phone216-362-0550
Emailservice@scottcare.com
Phone216-362-0550
Emailservice@scottcare.com
Phone216-362-0550
Emailservice@scottcare.com
Phone216-362-0550
Emailservice@scottcare.com
Phone216-362-0550
Emailservice@scottcare.com
Phone216-362-0550
Emailservice@scottcare.com
Phone216-362-0550
Emailservice@scottcare.com
Phone216-362-0550
Emailservice@scottcare.com
Phone216-362-0550
Emailservice@scottcare.com
Phone216-362-0550
Emailservice@scottcare.com
Phone216-362-0550
Emailservice@scottcare.com
Phone216-362-0550
Emailservice@scottcare.com
Phone216-362-0550
Emailservice@scottcare.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100856298006435 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

DXHTransmitters And Receivers, Electrocardiograph, Telephone

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-05-31
Device Publish Date2024-05-23

Devices Manufactured by SCOTTCARE CORPORATION, THE

00856298006428 - EZLink-R2024-05-31
00856298006435 - EZLink-C2024-05-31
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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