CARDINAL HEALTH

Basic Information

• Brand Name: CARDINAL HEALTH
• Primary DI: 10885380113079
• Version / Model: BEV-O-100
• Catalog Number: BEV-O-100
• Company Name: Cardinal Health 200, LLC
• Labeler DUNS: 961027315
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-08-15
• Public Version: 4
• Public Version Date: 2018-07-23
• Public Version Status: Update
• Public Device Record Key: d2d86953-d98c-4d9a-b01e-1e27f57caaba

Device Description

Beverage Glucose Tolerance Test Orange 100gm 10oz 24bt/cs

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: 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
MRV	DRINK, GLUCOSE TOLERANCE	Clinical Chemistry	862.1345	2

GMDN Terms

Code	Name	Definition	Implantable	Status
53307	Glucose IVD, reagent	A substance or reactant intended to be used together with a parent IVD to perform a specific function in an assay that is used for the quantitative measurement of glucose in a clinical specimen.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	50885380113077	GS1	CASE	24	In Commercial Distribution
Package	20885380113076	GS1	BOX	10	In Commercial Distribution
Primary	10885380113079	GS1

Premarket Submissions

Submission Number	Supplement Number
K120247	000