Halyard

Basic Information

• Brand Name: Halyard
• Primary DI: 20680651391180
• Version / Model: 39118
• Catalog Number: 39118-01
• Company Name: O&M HALYARD, INC.
• Labeler DUNS: 081057389
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 25
• Record Status: Published
• Publish Date: 2016-09-30
• Public Version: 4
• Public Version Date: 2020-04-06
• Public Version Status: Update
• Public Device Record Key: b0e138fa-c3dc-44ba-99d8-71167b0ef886

Device Description

HALYARD* FLUIDSHIELD* Level 1 Surgical Mask with SO SOFT* Lining and Horizontal Ties-Wraparound Visor with Anti-Glare

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• 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: No
• 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
FXX	Mask, surgical	General, Plastic Surgery	878.4040	2

GMDN Terms

Code	Name	Definition	Implantable	Status
11961	Face splash shield, single-use	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 single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	30680651391187	GS1	CS	4	In Commercial Distribution
Primary	20680651391180	GS1
Unit of Use	90680651391189	GS1

Customer Contacts

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