Cardiokey

GUDID B146CK0

Holter Recorder

BRAEMAR MANUFACTURING, LLC

Electrocardiographic ambulatory recorder
Primary Device IDB146CK0
NIH Device Record Key833e0177-a1cd-4077-b20e-03b43cd5b2fe
Commercial Distribution StatusIn Commercial Distribution
Brand NameCardiokey
Version Model Number100-0030-01
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
HIBCCB146CK0 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MWJElectrocardiograph,Ambulatory(Without Analysis)

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 Date2017-02-11

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

Trademark Results [Cardiokey]

Mark Image

Registration | Serial
Company
Trademark
Application Date
CARDIOKEY
CARDIOKEY
86461642 5418545 Live/Registered
Braemar Manufacturing, LLC
2014-11-21

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