- Physicians Office Resource

BILATERAL SENSOR
BIS - 186-0212

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

Storage Environment Temperature - Degrees Fahrenheit

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: 10884521134478

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: 90884521657850

Device Type: Package

DeviceId Issuing Agency: GS1

Contains DI Number: 20884521134475

Package Quantity: 9999

Package Discontinue Date: N/A

Package Status: In Commercial Distribution

Package Type: PALLET

Device Id: 30884521657858

Device Type: Package

DeviceId Issuing Agency: GS1

Contains DI Number: 10884521134478

Package Quantity: 10

Package Discontinue Date: N/A

Package Status: In Commercial Distribution

Package Type: PACK_OR_INNER_PACK

Device Id: 20884521134475

Device Type: Package

DeviceId Issuing Agency: GS1

Contains DI Number: 30884521657858

Package Quantity: 10

Package Discontinue Date: N/A

Package Status: In Commercial Distribution

Package Type: CASE

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