Halyard

Basic Information

• Brand Name: Halyard
• Primary DI: 20680651325741
• Version / Model: 32574
• Catalog Number: 32574
• Company Name: O&M HALYARD, INC.
• Labeler DUNS: 081057389
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 10
• Record Status: Published
• Publish Date: 2020-11-16
• Public Version: 1
• Public Version Date: 2020-11-24
• Public Version Status: New
• Public Device Record Key: 0cd38d08-9a13-412a-a85a-56e53c97db63

Device Description

HALYARD* Tri-Layer Over-the-Head Isolation Gowns, Universal, Yellow, 11" x 5.5" Fold

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: 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
OEA	Non-surgical isolation gown	General, Plastic Surgery	878.4040	1

GMDN Terms

Code	Name	Definition	Implantable	Status
35092	Patient gown, single-use	A non-sterile garment made of natural and/or synthetic materials (e.g., paper, cloth, plastic) intended to be worn by patients in a clinical setting (e.g., during hospitalization, during examination in a doctor's office). A patient gown is usually short-sleeved and may be closed by ties at the back/side of the garment. This is a single-use garment.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	30680651325748	GS1	CS	12	In Commercial Distribution
Primary	20680651325741	GS1
Unit of Use	90680651325740	GS1

Customer Contacts

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