FDA.reportPublic FDA data

ER920W First-Call Medical

Primary DI
B146ER9WFCM0
Brand
ER920W First-Call Medical
Company
BRAEMAR MANUFACTURING, LLC
Model
900-0581-57
Device description
Wireless Arrhythmia Event Recorder
Published
2017-02-11
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Product Codes#

Code, Name table
CodeName
DRGTransmitters And Receivers, Physiological Signal, Radiofrequency

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DRGTransmitters And Receivers, Physiological Signal, RadiofrequencyCardiovascular2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B146ER9WFCM0PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Electrocardiography telemetric monitoring systemAn assembly of devices designed to continuously measure and wirelessly transmit electrocardiographic (ECG) signals from a patient to a receiving location (e.g., central station, bedside monitor) for viewing. It typically consists of a portable transmitter with antenna and attached sensors (e.g., leads and electrodes) that are connected to the patient, as well as a receiver typically incorporated into a central station or bedside monitor that receives, consolidates, and displays the information. The system is typically used for ambulatory patients who require continuous monitoring (e.g., patients in step-down care areas).

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
049529118
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
true
Lot or batch
false
Serial number
true
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
B146C6R30C6 Sensor 3.0, Rebuilt02-021242024-06-26
B146EP25R0ePatch Sensor 2.5, Rebuilt02-022512024-06-26
B146C6M20C6 Monitor UGW100-0048-022019-10-08
B146EP2510ePatch 2.5, BTH02-020452023-01-20
B146EP2520ePatch 2.5, BTI02-020462023-11-22
B146C6M60C6 Monitor A10e, Sprint02-018002023-06-15
B146C6M80C6 Monitor A13, T Mobile02-021192023-06-15
B146C6M90C6 Monitor A13, Verizon02-021182023-06-15
B146EP2R10ePatch 2.0 rebuilt02-019972022-07-13
B146EPE1ePatch Electrode-patch02-001682022-03-31
B146C6M70C6 Monitor A10e, Verizon02-018042022-03-21
B146PE31 Universal electrode patch02-019092022-03-21
B146C6E10C6 Sensor 3.002-018462021-04-28
B146C6R10C6 Sensor 2.5 rebuilt02-018892021-03-30
B146C6R20C6 Sensor 2.0 rebuilt02-018972021-03-30
B146BTPA10BTP-1000A02-001432020-07-16
B146BTPA20BTP-1000A02-015762020-07-16
B146BTPL20BTP-1000L-202-007752020-07-16
B146BTPL210BTP-1000L-2 BTI02-015602020-07-16
B146BTPM0BTP-1000S Monitor100-0045-022020-07-15

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Primary DI, Brand, Company table
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10884521851559Vital SyncCovidien LPDRG2025-04-27
B353UA2251C1UbiqVue Lifesignals, Inc.DRG2025-04-22
B353UA2251S1UbiqVue Lifesignals, Inc.DRG2025-04-22
B353UA2251W1UbiqVue Lifesignals, Inc.DRG2025-04-22
B353UB12512UbiqVue HolterLifesignals, Inc.DRG2025-04-22
B353UB22512UbiqVue HolterLifesignals, Inc.DRG2025-04-22
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00850064210248Sibel Spacelabs Trek Chest Patch AdhesiveSibel Health Inc.DRG2025-04-02
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08056732652422HD+12CARDIOLINE SPADRG2025-02-26
08056732652712PATIENT CABLE SNAP 10 WIRES IEC FOR HD+ ORANGECARDIOLINE SPADRG2025-02-26
08056732652736PATIENT CABLE PLUG 10 WIRES AHA FOR HD+ ORANGECARDIOLINE SPADRG2025-02-26
10850005949555BioButton (Reprocessed)BIOINTELLISENSE, INC.DRG2025-02-19
10850005949562BioButton (Reprocessed, NF Version)BIOINTELLISENSE, INC.DRG2025-02-19
10850005949593BioButton Charging StationBIOINTELLISENSE, INC.DRG2025-02-19
10850005949449BioButton Rechargeable Device, Multi-PatientBIOINTELLISENSE, INC.DRG2025-02-11
10884521854260Vital SyncCovidien LPDRG2024-12-27