Primary Device ID | B146C6S0 |
NIH Device Record Key | 493fffa8-1b1d-4a32-a8d8-870bdf3c4353 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | BTP-1000S |
Version Model Number | 900-0634-00 |
Company DUNS | 049529118 |
Company Name | BRAEMAR MANUFACTURING, LLC |
Device Count | 1 |
DM Exempt | false |
Pre-market Exempt | false |
MRI Safety Status | Labeling does not contain MRI Safety Information |
Human Cell/Tissue Product | false |
Device Kit | false |
Device Combination Product | false |
Single Use | false |
Lot Batch | false |
Serial Number | true |
Manufacturing Date | false |
Expiration Date | false |
Donation Id Number | false |
Contains Natural Rubber Latex | false |
Labeled No Natural Rubber Latex | false |
RX Perscription | false |
OTC Over-The-Counter | false |
Device Issuing Agency | Device ID |
---|---|
HIBCC | B146C6S0 [Primary] |
DSI | Detector And Alarm, Arrhythmia |
Steralize Prior To Use | false |
Device Is Sterile | false |
Public Version Status | Update |
Device Record Status | Published |
Public Version Number | 2 |
Public Version Date | 2019-11-08 |
Device Publish Date | 2018-08-16 |
B146C6R30 - C6 Sensor 3.0, Rebuilt | 2024-07-04 |
B146EP25R0 - ePatch Sensor 2.5, Rebuilt | 2024-07-04 |
B146C6M20 - C6 Monitor UGW | 2023-12-14 |
B146EP2510 - ePatch 2.5, BTH | 2023-12-13 |
B146EP2520 - ePatch 2.5, BTI | 2023-11-30 |
B146C6M60 - C6 Monitor A10e, Sprint | 2023-06-23 |
B146C6M80 - C6 Monitor A13, T Mobile | 2023-06-23 |
B146C6M90 - C6 Monitor A13, Verizon | 2023-06-23 |