Biosensor Patch
ImagineMIC - IM1110
Device Description
An 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).
Environmental Conditions
- 75.00
- 30.00
- 40.00
- 0.00
- For Long-term storage of more than 30 days, maintain between 5 and 27 Degree Celsius
- 75.00
- 30.00
- 40.00
- 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: DRX
Device Name: Electrode, Electrocardiograph
Device Class: 2
Physical State: N/A
Definition: N/A
Submission Type ID: 4
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: 870.2360
Third Party Flag: N
Medical Specialty: CV
Code: DRT
Device Name: Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm)
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: 870.2300
Third Party Flag: Y
Medical Specialty: CV
Device IdentifiersDevice Id: B353IM11103
Device Type: Package
DeviceId Issuing Agency: HIBCC
Contains DI Number: B353IM11102
Package Quantity: 8
Package Discontinue Date: 4/30/2021 12:00:00 AM
Package Status: Not in Commercial Distribution
Package Type: Large Box
Device Id: B353IM11102
Device Type: Package
DeviceId Issuing Agency: HIBCC
Contains DI Number: B353IM11101
Package Quantity: 25
Package Discontinue Date: 4/30/2021 12:00:00 AM
Package Status: Not in Commercial Distribution
Package Type: BOX
Device Id: B353IM11101
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