4 Electrode Sensor For use with BIS Monitoring Systems
BIS - 186-0106
Device Description
A photoelectric device designed to be applied externally to the scalp/head of a patient for transcutaneous measurement [e.g., using near-infrared spectroscopy (NIRS)] of brain tissue blood oxygen saturation and/or venous oxygen saturation in the brain. It connects to a cerebral oximeter via a fibreoptic cable and typically consists of a single/dual adhesive sensing strip. This is a single-use device.
Environmental Conditions
- This side up; Keep Dry; Fragile
- 85.00
- 50.00
Device Sizes
No Data Available
Device Sterilization
Device Sterile: False
Sterilization Prior To Use: False
Sterilization Methods: No Data Available
Product Codes
Code: GXY
Device Name: Electrode, Cutaneous
Device Class: 2
Physical State: N/A
Definition: N/A
Submission Type ID: 1
Review Panel: NE
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: 882.1320
Third Party Flag: Y
Medical Specialty: NE
Device Identifiers
Device Id: 10884521133884
Device Type: Package
DeviceId Issuing Agency: GS1
Contains DI Number: 10884521134300
Package Quantity: 2
Package Discontinue Date: N/A
Package Status: In Commercial Distribution
Package Type: CASE
Device Id: 10884521134300
Device Type: Package
DeviceId Issuing Agency: GS1
Contains DI Number: 20884521134307
Package Quantity: 25
Package Discontinue Date: N/A
Package Status: In Commercial Distribution
Package Type: PACK_OR_INNER_PACK
Device Id: 20884521134307
Device Type: Primary
DeviceId Issuing Agency: GS1
Contains DI Number: N/A
Package Quantity: N/A
Package Discontinue Date: N/A
Package Status: N/A
Package Type: N/A
Device Id: 90884521657508
Device Type: Package
DeviceId Issuing Agency: GS1
Contains DI Number: 20884521134307
Package Quantity: 9999
Package Discontinue Date: N/A
Package Status: In Commercial Distribution
Package Type: PALLET
