ER9W CDMA UNM

GUDID B146ERWCD030

BRAEMAR MANUFACTURING, LLC

Electrocardiography telemetric monitoring system
Primary Device IDB146ERWCD030
NIH Device Record Keycf04db29-89e4-4372-b5f9-995d6c70a09f
Commercial Distribution StatusIn Commercial Distribution
Brand NameER9W CDMA UNM
Version Model Number900-0612-03
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
HIBCCB146ERWCD030 [Primary]

FDA Product Code

DRGTransmitters And Receivers, Physiological Signal, Radiofrequency

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-07-23
Device Publish Date2020-07-15

Devices Manufactured by BRAEMAR MANUFACTURING, LLC

B146C6R30 - C6 Sensor 3.0, Rebuilt2024-07-04
B146EP25R0 - ePatch Sensor 2.5, Rebuilt2024-07-04
B146C6M20 - C6 Monitor UGW2023-12-14
B146EP2510 - ePatch 2.5, BTH2023-12-13
B146EP2520 - ePatch 2.5, BTI2023-11-30
B146C6M60 - C6 Monitor A10e, Sprint2023-06-23
B146C6M80 - C6 Monitor A13, T Mobile2023-06-23
B146C6M90 - C6 Monitor A13, Verizon2023-06-23

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