Medline

Basic Information

• Brand Name: Medline
• Primary DI: 10080196193066
• Version / Model: HCS245E
• Catalog Number: HCS245E
• Company Name: MEDLINE INDUSTRIES, INC.
• Labeler DUNS: 025460908
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-06-08
• Public Version: 1
• Public Version Date: 2023-06-16
• Public Version Status: New
• Public Device Record Key: 8b8d7258-8961-4b0a-b862-85419787f9b6

Device Description

MASK,TRACHEOSTOMY,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: 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
BYG	MASK, OXYGEN	Anesthesiology	868.5580	1
KGB	MASK, OXYGEN, NON-REBREATHING	Anesthesiology	868.5570	1

GMDN Terms

Code	Name	Definition	Implantable	Status
35179	Tracheostomy mask, aerosol	A device designed to deliver air, oxygen, or a mixture of the two gases with aerosolized water particles to a patient who has a tracheostomy airway. It is typically connected to an oxygen source and nebulizer with wide bore tubing and is constructed of plastic. The device can be used over a tracheostomy tube or a stoma and is secured with a strap. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	40080196193067	GS1	CASE	50	In Commercial Distribution
Primary	10080196193066	GS1

Customer Contacts

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