McKesson

Basic Information

• Brand Name: McKesson
• Primary DI: 00612479197411
• Version / Model: 121-011
• Company Name: MCKESSON MEDICAL-SURGICAL INC.
• Labeler DUNS: 023904428
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 4
• Record Status: Published
• Publish Date: 2019-03-18
• Public Version: 1
• Public Version Date: 2019-03-26
• Public Version Status: New
• Public Device Record Key: c7cc87bf-f7db-4a62-9985-fac07366d8fc

Device Description

CONTROL, URINE DROPPER LEV1&2

Device Characteristics

• Single Use: No
• 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
JJW	Urinalysis Controls (Assayed And Unassayed)	Clinical Chemistry	862.1660	1

GMDN Terms

Code	Name	Definition	Implantable	Status
30219	Multiple urine analyte IVD, control	A material which is used to verify the performance of a number of assays intended to be used for the qualitative and/or semi-quantitative screening of urine for multiple analytes.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	00612479197428	GS1	Case	10	In Commercial Distribution
Primary	00612479197411	GS1
Unit of Use	00612479243637	GS1

Premarket Submissions

Submission Number	Supplement Number
K142543	000