Wearable Biosensor
LifeSignals - LP1250
Device Description
An electrically-powered, noninvasive device designed to be worn by a patient during daily activities for 24-hour recording of the electrocardiographic signals of the heart, for the diagnosis of cardiac disorders (e.g., arrhythmias). The recorded measurements can be downloaded and analysed at a medical facility, typically using a computer with a dedicated software. Otherwise known as a Holter monitor, the device typically incorporates display and controls, and may include surface electrodes, lead wires and accessories intended for attachment/removal (e.g., wipes, adhesive remover).
Environmental Conditions
- 90.00
- 10.00
- 45.00
- 0.00
- For long-term storage of more than 30 days, maintain between 5 and 27 Degrees Celsius
- 90.00
- 10.00
- 45.00
- 0.00
Device Sizes
No Data Available
Device Sterilization
Device Sterile: False
Sterilization Prior To Use: False
Sterilization Methods: No Data Available
Product Codes
Code: DRG
Device Name: Transmitters And Receivers, Physiological Signal, Radiofrequency
Device Class: 2
Physical State: N/A
Definition: N/A
Submission Type ID: 1
Review Panel: CV
Review Code: N/A
Technical Method: N
Gmp Exempt Flag: N/A
Life Sustain Support Flag: N
Unclassified Reason: N/A
Implant Flag: N
Target Area: N/A
Regulation Number: 870.2910
Third Party Flag: Y
Medical Specialty: CV
Code: MWJ
Device Name: Electrocardiograph, Ambulatory (Without Analysis)
Device Class: 2
Physical State: N/A
Definition: N/A
Submission Type ID: 1
Review Panel: CV
Review Code: N/A
Technical Method: N
Gmp Exempt Flag: N/A
Life Sustain Support Flag: N
Unclassified Reason: N/A
Implant Flag: N
Target Area: N/A
Regulation Number: 870.2800
Third Party Flag: N
Medical Specialty: CV
Device IdentifiersDevice Id: B353LP12502
Device Type: Package
DeviceId Issuing Agency: HIBCC
Contains DI Number: B353LP12501
Package Quantity: 25
Package Discontinue Date: 11/1/2023 12:00:00 AM
Package Status: Not in Commercial Distribution
Package Type: Small BOx
Device Id: B353LP12501
Device Type: Primary
DeviceId Issuing Agency: HIBCC
Contains DI Number: N/A
Package Quantity: N/A
Package Discontinue Date: N/A
Package Status: N/A
Package Type: N/A
Device Id: B353LP12503
Device Type: Package
DeviceId Issuing Agency: HIBCC
Contains DI Number: B353LP12502
Package Quantity: 8
Package Discontinue Date: 11/1/2023 12:00:00 AM
Package Status: Not in Commercial Distribution
Package Type: Big Box