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Sign in to claim this brandBraemar 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
- —
- —
- [email protected]
- Phone
- n/a
- PRRC Contact
- Sean Gibbons
- EUDAMED SRN
- US-MF-000036101
- FDA FEI Number
- 3003584029
- DUNS Number
- —
Catalogue (134)
Page 2 of 3| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| DL900 Forest Medical | 900-0570-23 | FDA UDI | Class II | Unknown |
| DL950 Patient Cable | 350-0318-01 | FDA UDI | Class II | Unknown |
| Millennia Software | 900-0621-02 | FDA UDI | Class II | Unknown |
| DL900 Base | 900-0570-26 | FDA UDI | Class II | Unknown |
| Er920w Ncmc | 900-0581-53 | FDA UDI | Class II | Active |
| ER920W Cardiomedix | 900-0581-06 | FDA UDI | Class II | Active |
| Btp-1000l-2 Bti | 02-01560 | FDA UDI | Class II | Active |
| ECAT2 Generic | 900-0623-01 | FDA UDI | Class II | Active |
| Epatch sensor | 900-0632-01 | FDA UDI | Class II | Active |
| Millennia Software | 900-0618-07 | FDA UDI | Class II | Unknown |
| DL800 Patient Cable | 350-0235-03 | FDA UDI | Class II | Unknown |
| ER920W First-Call Medical | 900-0581-57 | FDA UDI | Class II | Active |
| Millennia Software | 900-0620-00 | FDA UDI | Class II | Unknown |
| ER920W CardioLabs | 900-0581-58 | FDA UDI | Class II | Active |
| Btp-1000m | 02-01548 | FDA UDI | Class II | Active |
| Fusion First Call Medical | 900-0584-50 | FDA UDI | Class II | Active |
| ER9W Cardiomedix | 900-0612-05 | FDA UDI | Class II | Active |
| Btp-1000lw | 02-00124 | FDA UDI | Class II | Active |
| Millennia Software | 900-0619-08 | FDA UDI | Class II | Unknown |
| DL950 Braemar Standard | 900-0616-03 | FDA UDI | Class II | Unknown |
| C6 Monitor A10e, Sprint | 02-01800 | FDA UDI | Class II | Active |
| C6 Sensor 3.0, Rebuilt | 02-02124 | FDA UDI | Class II | Active |
| DL950 patient Cable | 350-0318-00 | FDA UDI | Class II | Unknown |
| DL900 Braemar 7day | 900-0570-16 | FDA UDI | Class II | Unknown |
| ER920W Braemar | 900-0581-00 | FDA UDI | Class II | Active |
| DL800 Patient Cable | 350-0235-00 | FDA UDI | Class II | Unknown |
| DL800 Biomedical SYS | 900-0543-19 | FDA UDI | Class II | Unknown |
| DL800 Braemar 256 s/s 10 bit | 900-0543-09 | FDA UDI | Class II | Unknown |
| Btp-1000a | 02-01576 | FDA UDI | Class II | Active |
| ePatch | 900-0630-00 | FDA UDI | Class II | Active |
| Fusion TLC | 900-0584-49 | FDA UDI | Class II | Active |
| Millennia Software | 900-0621-08 | FDA UDI | Class II | Unknown |
| ER920W Life Support | 900-0581-44 | FDA UDI | Class II | Active |
| C6 Sensor 2.5 rebuilt | 02-01889 | FDA UDI | Class II | Active |
| Universal electrode-patch | 02-01609 | FDA UDI | Class II | Active |
| Cardiokey | 100-0030-01 | FDA UDI | Class II | Unknown |
| DL950 Braemar | 900-0616-01 | FDA UDI | Class II | Unknown |
| Epatch Sensor | 900-0632-05 | FDA UDI | Class II | Active |
| ER9W 3GSM Brookings | 900-0614-02 | FDA UDI | Class II | Active |
| DL900 Burdick 4250 | 900-0570-19 | FDA UDI | Class II | Unknown |
| C6 Monitor | 02-01549 | FDA UDI | Class II | Active |
| MCOT Electrode BTH | 390-0131-02 | FDA UDI | Class II | Unknown |
| Btp-1000l-2 | 02-00139 | FDA UDI | Class II | Active |
| DL950 Braemar | 900-0616-00 | FDA UDI | Class II | Unknown |
| Er9w Ami | 900-0612-06 | FDA UDI | Class II | Active |
| DL800 Norav 256 s/s 8bit | 900-0543-12 | FDA UDI | Class II | Unknown |
| ER920 Braemar | 900-0557-01 | FDA UDI | Class II | Active |
| ePatch | 900-0632-00 | FDA UDI | Class II | Active |
| DL900 Standard | 900-0570-27 | FDA UDI | Class II | Unknown |
| ER9W CDMA First Call Med | 900-0612-02 | FDA UDI | Class II | Active |
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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. |