Medline

Basic Information

• Brand Name: Medline
• Primary DI: 10888277675674
• Version / Model: MPH6540
• Catalog Number: MPH6540
• Company Name: MEDLINE INDUSTRIES, INC.
• Labeler DUNS: 025460908
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2020-05-29
• Public Version: 1
• Public Version Date: 2020-06-08
• Public Version Status: New
• Public Device Record Key: 07ecb2ad-e4a0-4db6-92b3-e71b8a5110c9

Device Description

METER, GLUCOSE, HARMONY,PROF.USE ONLY

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• Over the Counter (OTC): Yes
• 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
FLL	Thermometer, electronic, clinical	General Hospital	880.2910	2

GMDN Terms

Code	Name	Definition	Implantable	Status
62954	Her2/neu/erbB2 gene mutation IVD, probe	A defined piece of single-stranded nucleic acid which is used to identify specific complementary-sequence nucleic acid molecules in an assay intended to be used to evaluate a clinical specimen to diagnose, monitor or predict genetic mutations (e.g., duplication) of the her2/neu/erbB2 [v-erb-B2 avian erythroblastic leukaemia viral oncogene homolog 2] gene, associated with solid malignant neoplasms (e.g., breast cancer, ovarian cancer, stomach cancer, carcinoma of the salivary glands).	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	10888277675674	GS1

Customer Contacts

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