Epatch Sensor

GUDID B146EP04

BRAEMAR MANUFACTURING, LLC

Electrocardiographic ambulatory recorder
Primary Device IDB146EP04
NIH Device Record Key4d5b8e0a-4e35-43de-bd4a-2beecd3d1a20
Commercial Distribution StatusIn Commercial Distribution
Brand NameEpatch Sensor
Version Model Number900-0632-02
Company DUNS049529118
Company NameBRAEMAR MANUFACTURING, LLC
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 Numbertrue
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
HIBCCB146EP04 [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 Date2019-11-08
Device Publish Date2019-10-09

On-Brand Devices [Epatch Sensor]

B146EP080900-0632-05
B146EP070900-0632-04
B146EP060900-0632-03
B146EP04900-0632-02
B146EP030900-0632-01

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