MEDLINE

Basic Information

• Brand Name: MEDLINE
• Primary DI: 20888277717777
• Version / Model: MPH42025HP
• Catalog Number: MPH42025HP
• Company Name: MEDLINE INDUSTRIES, INC.
• Labeler DUNS: 025460908
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 25
• Record Status: Published
• Publish Date: 2024-08-08
• Public Version: 1
• Public Version Date: 2024-08-16
• Public Version Status: New
• Public Device Record Key: a63f148b-18d9-4507-88fc-45848818aa3a

Device Description

TEST,H.PYLORI,CASS,25 TEST

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• 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: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• 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
LYR	Helicobacter pylori	Microbiology	866.3110	1

GMDN Terms

Code	Name	Definition	Implantable	Status
50998	Helicobacter pylori antigen IVD, control	A material which is used to verify the performance of an assay intended to be used for the qualitative and/or quantitative detection of antigens from Helicobacter pylori bacteria in a clinical specimen.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Unit of Use	10888277717770	GS1
Primary	20888277717777	GS1

Customer Contacts

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

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 35 – 86 Degrees Fahrenheit