Mizzy Comfort Cushion

Basic Information

• Brand Name: Mizzy Comfort Cushion
• Primary DI: H66860701551
• Version / Model: 6070155
• Catalog Number: 6070155
• Company Name: Keystone Industries
• Labeler DUNS: 073503117
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 2
• Record Status: Published
• Publish Date: 2022-11-30
• Public Version: 1
• Public Version Date: 2022-12-08
• Public Version Status: New
• Public Device Record Key: 6b11c198-6eb4-479c-b40a-f79775c029d5

Device Description

Head Strap (2 Per Bag)

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: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: Yes
• Has Serial Number: No
• Has Lot/Batch Number: No
• 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
BTK	STRAP, HEAD, GAS MASK	Anesthesiology	868.5560	1

GMDN Terms

Code	Name	Definition	Implantable	Status
31254	Anaesthesia mask strap, reusable	A band of material designed to hold an anaesthesia mask in position on a patient's face. It is typically wrapped around the patient's head and often affixed to a special stabilizing device (e.g., with hooks) located on the gas connection port of the mask. It is typically used for anaesthesia of long duration. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Unit of Use	H66860701550	HIBCC
Primary	H66860701551	HIBCC

Customer Contacts

• Phone: [phone] ext. 8455
• Email: [email protected]