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Braemar Manufacturing, LLC

United States·US-MF-000036101

Last updated September 17, 2026

Information

Country: United States
Address: 1285, Corporate Center Drive, Eagan, United States
Website: n/a
LinkedIn: —
Facebook: —
Email: [email protected]
Phone: n/a
PRRC Contact: Sean Gibbons
EUDAMED SRN: US-MF-000036101
FDA FEI Number: 3003584029
DUNS Number: —

Catalogue (134)

Page 3 of 3

Device	Model / Reference	Registries	Class	Status
C6 Monitor A13, T Mobile	02-02119	FDA UDI	Class II	Active
PER900 Braemar	900-0553-03	FDA UDI	Class II	Active
DL900 Norav Encrypted	900-0570-24	FDA UDI	Class II	Unknown
Universal electrode patch	02-01909	FDA UDI	Class II	Active
DL900 Braemar SD	900-0570-10	FDA UDI	Class II	Unknown
Epatch Sensor	900-0632-03	FDA UDI	Class II	Active
ePatch 2.0 rebuilt	02-01997	FDA UDI	Class II	Active
ER920 Rozinn, AFIB	900-0557-07	FDA UDI	Class II	Active
DL800 Norav	900-0543-20	FDA UDI	Class II	Unknown
Millennia Software	900-0620-08	FDA UDI	Class II	Unknown
C6 Sensor 2.0 rebuilt	02-01897	FDA UDI	Class II	Active
DL800 CardioLabs	900-0543-11	FDA UDI	Class II	Unknown
ER920W CardioNet	900-0581-47	FDA UDI	Class II	Active
Millennia Software	900-0618-08	FDA UDI	Class II	Unknown
Millennia Software	900-0620-05	FDA UDI	Class II	Unknown
DL800 Norav Encrypted	900-0543-21	FDA UDI	Class II	Unknown
Er9w Cdma Unm	900-0612-03	FDA UDI	Class II	Active
Millennia Software	900-0618-05	FDA UDI	Class II	Unknown
ER9W CDMA wEvent	900-0612-01	FDA UDI	Class II	Active
Millennia Software	900-0618-01	FDA UDI	Class II	Unknown
Fusion Braemar	900-0584-10	FDA UDI	Class II	Active
ER920 Rozinn	900-0557-06	FDA UDI	Class II	Active
ER920W Brookings Health	900-0581-54	FDA UDI	Class II	Active
DL900 Norav 7 day CE	900-0570-15	FDA UDI	Class II	Unknown
Cardiokey Leadwire	390-0124-02	FDA UDI	Class II	Unknown
Dl900	900-0570-28	FDA UDI	Class II	Unknown
ePatch electrode-patch	390-0240-02	FDA UDI	Class II	Active
C5 Monitor	100-0025-01	FDA UDI	Class II	Active
Braemar Cardiokey Holter Recorder	K130294	FDA 510(k)	Class II	Active
ePatch 2.5 Sensor	02-02046	EUDAMEDFDA UDI	Class IIa	Active
Patch	02-01639	EUDAMEDFDA UDI	Class I	Active
Patch	02-01640	EUDAMEDFDA 510(k)	Class I	Active
ePatch 2.0 Sensor	02-01650	EUDAMEDFDA UDI	Class IIa	Active
ePatch	02-00168	EUDAMEDFDA UDI	Class I	Active

Related Companies

Authorised Representatives

Philips Medical Systems Nederland B.V. NL

Importers

Not available yet.

Notified Bodies

Not available yet.

Authorities

Not available yet.

FDA Recalls (3)

Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.

Date	Recall No.	Class	Status	Reason
Dec 18, 2024	Z-0708-2025	—	open, classified	Not all Electrocardiogram (ECG) events received July 2022-July 2024 were not properly routed and subsequently reviewed due to an analysis step being disabled with the monitoring service application software.
Jan 22, 2020	Z-1460-2020	—	terminated	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 study. There are no actions that a clinical user can take to clear this error. Even if this error code is displayed, existing ECG recordings stored on the device can still be downloaded via the standard Holter Application Software. Error 602 may be able to be cleared by technical or engineering staff at the customer site.
Jan 22, 2020	Z-1459-2020	—	terminated	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 study. There are no actions that a clinical user can take to clear this error. Even if this error code is displayed, existing ECG recordings stored on the device can still be downloaded via the standard Holter Application Software. Error 602 may be able to be cleared by technical or engineering staff at the customer site.