HET

Basic Information

• Brand Name: HET
• Primary DI: 10884521511149
• Version / Model: 180-1007
• Company Name: Covidien LP
• Labeler DUNS: 058614483
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-24
• Public Version: 6
• Public Version Date: 2022-11-15
• Public Version Status: Update
• Public Device Record Key: 640c2beb-c2ac-424c-b4fa-8802b2bd8c3a

Device Description

Temperature Monitor

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: Yes
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: Yes
• Sterilization Methods: Dry Heat Sterilization

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
GEI	ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES	General, Plastic Surgery	878.4400	2

GMDN Terms

Code	Name	Definition	Implantable	Status
35632	Electrosurgical system monitor/alarm	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	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	10884521511149	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K140422	000

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: Keep Dry
• Type: Storage Environment Temperature
• Temperature Range: -29 – 149 Degrees Fahrenheit