Sharn Inc

Basic Information

• Brand Name: Sharn Inc
• Primary DI: 00817518021393
• Version / Model: 42827
• Catalog Number: 42827
• Company Name: Sharn Anesthesia
• Labeler DUNS: 107996118
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 12
• Record Status: Published
• Publish Date: 2018-10-10
• Public Version: 2
• Public Version Date: 2020-02-24
• Public Version Status: Update
• Public Device Record Key: e9e748fd-6ae3-4492-9ab8-1da8f9aee90a

Device Description

Moving Line Temperature Indicator

Device Characteristics

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

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
KPD	STRIP, TEMPERATURE, FOREHEAD, LIQUID CRYSTAL	General Hospital	880.2200	2

GMDN Terms

Code	Name	Definition	Implantable	Status
33618	Liquid-crystal patient thermometer, single-use	A device designed to measure a patient's skin, oral, rectal, or axillary (armpit) body temperature. It uses liquid-crystal sensors (usually formed from esters of cholesterol) that are sealed in a plastic band and appear to change colour at indicated temperatures. The device may be used in the home. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00817518021393	GS1
Unit of Use	00817518021829	GS1

Customer Contacts

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