DeRoyal

Basic Information

• Brand Name: DeRoyal
• Primary DI: 00749756039024
• Version / Model: 83-100202
• Catalog Number: 83-100202
• Company Name: DEROYAL INDUSTRIES, INC.
• Labeler DUNS: 096372255
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2021-07-12
• Public Version: 1
• Public Version Date: 2021-07-20
• Public Version Status: New
• Public Device Record Key: 6bc1fbca-14f1-44d2-b4c0-e1a1e8c4c890

Device Description

Mask,Anesthesia Adult

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: No
• 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
BSJ	MASK, GAS, ANESTHETIC	Anesthesiology	868.5550	1

GMDN Terms

Code	Name	Definition	Implantable	Status
60882	Anaesthesia mask strap, single-use	A non-sterile, non-latex strap/head harness intended to hold an anaesthesia mask in position on a patient's face. It is typically wrapped around the patient's head and affixed to the mask. It is typically used for anaesthesia of long duration. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	50749756039029	GS1	Case	50	In Commercial Distribution
Primary	00749756039024	GS1

Customer Contacts

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