CARDINAL HEALTH

Basic Information

• Brand Name: CARDINAL HEALTH
• Primary DI: 10885380151927
• Version / Model: CHUA215
• Catalog Number: CHUA215
• Company Name: Cardinal Health 200, LLC
• Labeler DUNS: 961027315
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2019-05-16
• Public Version: 3
• Public Version Date: 2020-08-10
• Public Version Status: Update
• Public Device Record Key: 3b1e4f31-eb33-4028-8d38-2e60a087fee9
• Distribution End Date: 2020-08-10

Device Description

UA Control Tube Abnormal -90mL

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• Over the Counter (OTC): Yes
• Kit: No
• Combination Product: No
• HCT/P: Yes
• 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: 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	50885380151925	GS1	BOX	6	Not in Commercial Distribution	2020-08-10
Primary	10885380151927	GS1

Device Sizes

Type	Value	Unit	Text
Total Volume	15	Milliliter

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 2 – 8 Degrees Celsius