Halyard

Basic Information

• Brand Name: Halyard
• Primary DI: 20680651480341
• Version / Model: 48034
• Catalog Number: 48034
• Company Name: O&M HALYARD, INC.
• Labeler DUNS: 081057389
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 300
• Record Status: Published
• Publish Date: 2020-09-15
• Public Version: 2
• Public Version Date: 2022-12-05
• Public Version Status: Update
• Public Device Record Key: f5345b18-7833-413e-bfab-176a819823b3

Device Description

AQUASOFT ZERO* Powder-Free Nitrile Exam Gloves, S

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: Yes
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
LZC	Patient examination glove, specialty	General Hospital	880.6250	1

GMDN Terms

Code	Name	Definition	Implantable	Status
56886	Cancer antigen 15-3 (CA15-3) IVD, kit, enzyme immunohistochemistry	A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of cancer antigen 15-3 (CA15-3), a marker commonly associated with breast cancer, in a clinical specimen using an enzyme immunohistochemistry method.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	30680651480348	GS1	CS	10	In Commercial Distribution
Primary	20680651480341	GS1
Unit of Use	90680651480340	GS1

Customer Contacts

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