Mcot Patch

Primary DI
B146MCP1
Brand
Mcot Patch
Company
BRAEMAR MANUFACTURING, LLC
Model
390-0131-02
Published
2019-10-03
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
true

Product Codes#

Code, Name table
CodeName
DRXElectrode, Electrocardiograph
IKDCable, Electrode

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DRXElectrode, ElectrocardiographCardiovascular2
IKDCable, ElectrodePhysical Medicine2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B146MCP1PackageHIBCC40In Commercial Distribution
B146MCP0PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Electrocardiographic lead set, reusableA collection of noninvasive devices intended to be used to conduct electrical signals from a patient's heart, via an electrode attached to the surface of the chest/limbs, to an electrocardiograph (ECG) machine or a patient monitoring system. It includes an insulated metal wire(s) with a detachable or permanently attached electrode, and may include a cable with connector; some types may be designed as a pre-configured array (e.g., EEG belt) to assist electrode placement. This is a reusable device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
049529118
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
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
00884838128729C6 Monitor A13, Verizon02-023862025-10-06
00884838128736C6 Monitor A13, T Mobile02-023872025-10-06
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
B146C6M70C6 Monitor A10e, Verizon02-018042022-03-21
B146C6E10C6 Sensor 3.002-018462021-04-28
B146C6R10C6 Sensor 2.5 rebuilt02-018892021-03-30
B146C6R20C6 Sensor 2.0 rebuilt02-018972021-03-30
B146BTPM0BTP-1000S Monitor100-0045-022020-07-15
B146C6M40C6 Monitor02-015492020-07-15
B146EP2020ePatch 2.0 BTI02-016502020-07-15
B146C6D0C6 Sensor D02-015612019-10-08
B146C6D10C6 Sensor 02-016062019-10-10

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07613327688788N/ASTRYKER SUSTAINABILITY SOLUTIONS, INC.IKD2026-04-06
07613327643237N/ASTRYKER SUSTAINABILITY SOLUTIONS, INC.IKD2024-08-08
07613327643244N/ASTRYKER SUSTAINABILITY SOLUTIONS, INC.IKD2024-08-08
08033695721525NAFIAB SPAIKD2021-07-08
08033003267424NAFIAB SPADRX2021-03-31
08033003260357NAFIAB SPADRX2020-06-13
08033003260364NAFIAB SPADRX2020-06-13
08033003260371NAFIAB SPADRX2020-06-13
08033003261507NAFIAB SPADRX2020-06-13
08033003261675NAFIAB SPADRX2020-06-13
08033003261682NAFIAB SPADRX2020-06-13
08033003262689NAFIAB SPADRX2020-06-13
08033003262719NAFIAB SPADRX2020-06-13
08033003262726NAFIAB SPADRX2020-06-13
08033003262733NAFIAB SPADRX2020-06-13
08033003262887NAFIAB SPADRX2020-06-13
08033003264577NAFIAB SPADRX2020-06-13
08033695721983NAFIAB SPADRX2020-06-13
08033695722027NAFIAB SPADRX2020-06-13
08033695722034NAFIAB SPADRX2020-06-13
08033695722041NAFIAB SPADRX2020-06-13
08033695723369NAFIAB SPADRX2020-06-13
08033695725318NAFIAB SPADRX2020-06-13
08033695725417NAFIAB SPADRX2020-06-13
08033695725639NAFIAB SPADRX2020-06-13
08033695725936NAFIAB SPADRX2020-06-13
08033695726032NAFIAB SPADRX2020-06-13
08033695726094NAFIAB SPADRX2020-06-13
08033695726278NAFIAB SPAIKD2020-06-13
08033695726506NAFIAB SPADRX2020-06-13