McKesson

Basic Information

• Brand Name: McKesson
• Primary DI: 20612479269853
• Version / Model: 16-DFY-A102C
• Company Name: MCKESSON MEDICAL-SURGICAL INC.
• Labeler DUNS: 023904428
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 25
• Record Status: Published
• Publish Date: 2024-02-19
• Public Version: 1
• Public Version Date: 2024-02-27
• Public Version Status: New
• Public Device Record Key: 54d28d75-c22d-49ff-9ca5-f5e922ce9916

Device Description

TEST KIT, FENTANYL URINE RAPID (25/kt)

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• Over the Counter (OTC): Yes
• Kit: Yes
• 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: 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
NGL	Test, Opiates, Over The Counter	Clinical Toxicology	862.3650	2

GMDN Terms

Code	Name	Definition	Implantable	Status
63018	Fentanyl IVD, kit, enzyme immunoassay (EIA)	A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of fentanyl in a clinical specimen, using an enzyme immunoassay (EIA) method.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	40612479269864	GS1	Case	40	In Commercial Distribution
Primary	20612479269853	GS1
Unit of Use	10612479271255	GS1

Premarket Submissions

Submission Number	Supplement Number
K233417	000