Intubation Shield

Basic Information

• Brand Name: Intubation Shield
• Primary DI: 00857387006565
• Version / Model: 20-P01-00-0000
• Catalog Number: 20-P01-00-0000
• Company Name: PARAGON MEDICAL, INC.
• Labeler DUNS: 609244454
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2020-04-14
• Public Version: 1
• Public Version Date: 2020-04-22
• Public Version Status: New
• Public Device Record Key: 29536b00-6ef5-4670-bdb9-478be295463f

Device Description

Intubation Shield

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• 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: Yes
• Sterilization Methods: Moist Heat or Steam Sterilization

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
LYU	Accessory, Surgical Apparel	General, Plastic Surgery	878.4040	1

GMDN Terms

Code	Name	Definition	Implantable	Status
64779	Face splash shield, reusable	A clear, transparent guard intended to provide full face cover, to protect (shield) the healthcare worker from blood and other body fluid splashes while performing a clinical or laboratory procedure. It is commonly known as a splash shield. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00857387006565	GS1

Customer Contacts

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