COR12

GUDID 04251341900344

CORSCIENCE GmbH & Co. KG

Electrocardiograph, professional, multichannel Electrocardiograph, professional, multichannel Electrocardiograph, professional, multichannel Electrocardiograph, professional, multichannel Electrocardiograph, professional, multichannel Electrocardiograph, professional, multichannel Electrocardiograph, professional, multichannel Electrocardiograph, professional, multichannel Electrocardiograph, professional, multichannel Electrocardiograph, professional, multichannel Electrocardiograph, professional, multichannel Electrocardiograph, professional, multichannel Electrocardiograph, professional, multichannel Electrocardiograph, professional, multichannel

Primary Device ID	04251341900344
NIH Device Record Key	ec0d9f47-26b9-48ba-9efa-873eb8a294b6
Commercial Distribution Status	In Commercial Distribution
Brand Name	COR12
Version Model Number	CS10785-14
Company DUNS	333427776
Company Name	CORSCIENCE GmbH & Co. KG
Device Count	1
DM Exempt	false
Pre-market Exempt	false
MRI Safety Status	Labeling does not contain MRI Safety Information
Human Cell/Tissue Product	false
Device Kit	false
Device Combination Product	false
Single Use	false
Lot Batch	false
Serial Number	true
Manufacturing Date	false
Expiration Date	false
Donation Id Number	false
Contains Natural Rubber Latex	false
Labeled No Natural Rubber Latex	false
RX Perscription	true
OTC Over-The-Counter	false

Device Identifiers

Device Issuing Agency	Device ID
GS1	04251341900344 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K183369

FDA Product Code

DPS	Electrocardiograph

Sterilization

Steralize Prior To Use	false
Device Is Sterile	false

Device Entry Metadata

Public Version Status	New
Device Record Status	Published
Public Version Number	1
Public Version Date	2021-07-09
Device Publish Date	2021-07-01

On-Brand Devices [COR12]

04251341900115	CS10785-02
04251341900108	CS10785-01
04251341900344	CS10785-14
04251341900252	CS10785-09