Chroma2 7 Lead Patient Cable 101928

GUDID 00856298006107

5 lead ECG patient cable to be used with the Chroma2 device.

SCOTTCARE CORPORATION, THE

Electrocardiograph, professional, multichannel
Primary Device ID00856298006107
NIH Device Record Keyfcc2156f-782f-4c70-ae64-6a8d22703152
Commercial Distribution StatusIn Commercial Distribution
Brand NameChroma2 7 Lead Patient Cable
Version Model NumberChroma2 7 Lead Patient Cable
Catalog Number101928
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 Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
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

Device Identifiers

Device Issuing AgencyDevice ID
GS100856298006107 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

DRGTransmitters And Receivers, Physiological Signal, Radiofrequency

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
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
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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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