Temperature Monitor

Temperature Monitor
HET - 180-1007

A device designed to detect an interruption in dispersive cable continuity between an electrosurgical system generator and the dispersive (return) electrode, potentially due to current leakage. This device functions as a special form of patient circuit safety monitor and will give an alarm when a pre-set safety limit is exceeded. This is a stand-alone device; its function is typically built into modern electrosurgical units.

No Data Available

Device Sterile: False

Sterilization Prior To Use: True

Sterilization Methods:

• Dry Heat Sterilization

Code: GEI

Device Name: Electrosurgical, Cutting & Coagulation & Accessories

Device Class: 2

Physical State: N/A

Definition: Validated reprocessing instructions and reprocessing validation data for this device type must be included in a 510(k) submission if the device is reusable and has specific design features (please refer to Table 2 of 82 FR 26807, available at https://www.gpo.gov/fdsys/pkg/FR-2017-06-09/pdf/2017-12007.pdf).

Submission Type ID: 1

Review Panel: SU

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: 878.4400

Third Party Flag: Y

Medical Specialty: SU

Device Id: 10884521511156

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