DeRoyal

Basic Information

• Brand Name: DeRoyal
• Primary DI: 00749756049849
• Version / Model: 81-010000
• Company Name: DEROYAL INDUSTRIES, INC.
• Labeler DUNS: 096372255
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-12
• Public Version: 4
• Public Version Date: 2021-08-11
• Public Version Status: Update
• Public Device Record Key: 121af05a-4183-4e48-b50a-109765764fb9

Device Description

SensoStrip Temperature Indicator

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• 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: Yes
• PM Exempt: Yes
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: Yes
• 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
Package	50749756049844	GS1	Case	100	In Commercial Distribution
Primary	00749756049849	GS1
Package	30749756049840	GS1	Box	100	In Commercial Distribution

Customer Contacts

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