ER920W Patient Cable

GUDID B146ER990

BRAEMAR MANUFACTURING, LLC

Electrocardiographic lead set, reusable
Primary Device IDB146ER990
NIH Device Record Key268b37ae-c25b-4618-ae5d-7a39064182a0
Commercial Distribution StatusIn Commercial Distribution
Brand NameER920W Patient Cable
Version Model Number350-0173-09
Company DUNS049529118
Company NameBRAEMAR MANUFACTURING, LLC
Device Count1
DM Exemptfalse
Pre-market Exempttrue
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 Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCB146ER990 [Primary]

FDA Product Code

IKDCable, Electrode

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2019-10-21
Device Publish Date2019-10-08

On-Brand Devices [ER920W Patient Cable]

B146ER990350-0173-09
B146ER9100350-0173-10

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