ECG Leadwire Set for CM 3000 Series 2014606-039

GUDID 04250903200250

The cable is intended to be used to conduct electrical signals from a patient's heart, via an electrode attached to the surface of the chest/limbs, to

getemed Medizin- und Informationstechnik AG

Electrocardiographic lead set, reusable
Primary Device ID04250903200250
NIH Device Record Key46d6b1bc-e4a0-411a-b7f6-1c97fe8a7ae2
Commercial Distribution StatusIn Commercial Distribution
Brand NameECG Leadwire Set for CM 3000 Series
Version Model Number7 Leads, 60 cm, Colors: Red, Brown, Black, White,
Catalog Number2014606-039
Company DUNS331682898
Company Namegetemed Medizin- und Informationstechnik AG
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 Batchfalse
Serial Numberfalse
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numbertrue
Contains Natural Rubber Latextrue
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+49332939420
Emailinfo@getemed.de

Operating and Storage Conditions

Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -25 Degrees Celsius and 70 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS104250903200250 [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 Date2016-09-21

On-Brand Devices [ECG Leadwire Set for CM 3000 Series]

04250903200281The cable is intended to be used to conduct electrical signals from a patient's heart, via an el
04250903200250The cable is intended to be used to conduct electrical signals from a patient's heart, via an el
04250903200243The cable is intended to be used to conduct electrical signals from a patient's heart, via an el

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