Halyard

Basic Information

• Brand Name: Halyard
• Primary DI: 20680651693185
• Version / Model: 69318
• Catalog Number: 69318
• Company Name: O&M HALYARD, INC.
• Labeler DUNS: 081057389
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 15
• Record Status: Published
• Publish Date: 2019-06-28
• Public Version: 1
• Public Version Date: 2019-07-08
• Public Version Status: New
• Public Device Record Key: 0489d1b2-bcec-41a1-91f8-e30c7a28665a

Device Description

Film Gown, Blue, Open Back, Thumb Hooks, Universal Size

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
LYU	ACCESSORY, SURGICAL APPAREL	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	30680651693182	GS1	CS	5	In Commercial Distribution
Primary	20680651693185	GS1
Unit of Use	90680651693184	GS1

Customer Contacts

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