Data / Medical devices / United States / Braemar Manufacturing, LLC

Braemar Manufacturing, LLC: FDA-registered device maker in Eagan, MN, United States, 2 510(k) clearances

Name: Braemar Manufacturing, LLC FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Braemar Manufacturing, LLC is registered with the FDA (registration 2133409) in Eagan, MN, United States. It lists 4 device types. The FDA files 2 510(k) clearances under its listings, the newest dated January 4, 2018. 3 recall events name it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number: 2133409
FEI number: 1000520785
Address: 1285 Corporate Center Dr Ste 150, Eagan, MN, United States, 55121
Owner or operator: Philips Medical Systems International BV (1217116)
Roles: Complaint file establishment, Manufacturer
First device listed: November 12, 2003
Registered through: 2026
Brand names listed: 2-CH Patch, 40494E, Limb Clamp Electrode, 989803157481, DigiTrak XT Patient Cable, short, 989803157491, DigiTrak XT Patient Cable, Medium, 989803157501, DigiTrak XT Patient Cable, Long, BTP-1000A-Hybrid Patch, BTP-1000L-2-Lead Wire Adapter, BTP-1000M (Monitor) and more

Devices it lists

Device	Product code	Class	Role	Source
Cable, Electrode	IKD	2	Complaint file establishment, Manufacturer	accessdata.fda.gov
Detector And Alarm, Arrhythmia	DSI	2	Complaint file establishment, Manufacturer	accessdata.fda.gov
Electrode, Electrocardiograph	DRX	2	Complaint file establishment, Manufacturer	accessdata.fda.gov
Recorder, Magnetic Tape, Medical	DSH	2	Complaint file establishment, Manufacturer	accessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided	510(k) number	Device	Product code	Decision	Applicant	Source
January 4, 2018	K171410	ePatch	DSH	Substantially Equivalent	Braemar Manufacturing, LLC	accessdata.fda.gov
July 22, 2016	K153473	Braemar Telemetry Patch System	DSI	Substantially Equivalent	Braemar Manufacturing, LLC	accessdata.fda.gov

Recalls

Recall events where this establishment is the recalling firm, matched on its FEI.

Initiated	Event	Class	Status	Product	Reason	Source
January 22, 2020	84883	Class II	Terminated	Braemar Manufacturing LLC DL900 Holter Monitor 1285 Corporate Center Dr. Suite 150 Eagan, MN 55121 USA Rx Only	An issue with the DL900 and DL950 Series Holter Recorder was recognized on January 1, 2020. This issue can prevent the recorder from operating normally. Braemar confirmed that beginning on January 1, 2020 if a AAA battery is inserted in the recorder and a user attempts to start it, the recorder will display Error: 602 and fail to function for a new patient s	accessdata.fda.gov
February 24, 2012	65410	Class II	Terminated	Lithium Thionyl non-rechargeable disposable battery pack P/N 350-0294-01 used with ER920 Wireless Series Arrhythmia Event Recorder. Non-rechargeable disposable battery pack.	Braemar has recently became aware of a battery related incident that occurred with EWT battery packs that are used in a Braemer ER920W wireless event monitor and Fusion device. The event did not result in any patient related injury or present any clinical impact.	accessdata.fda.gov
May 2, 2011	65423	Class II	Terminated	Lithium Thionyl non-rechargeable disposable battery pack P/N 350-0294-00 used with ER920 Wireless Series Arrhythmia Event Recorder. Non-rechargeable disposable battery pack.	Braemar Inc., became aware of a battery related incident that occurred with an Able battery pack being used in a Braemar ER920W wireless event monitor. The event did not result in any patient related injury or present any clinical impact.	accessdata.fda.gov

Compare with other makers

Updated January 4, 2018. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.