CARDINAL HEALTH

Basic Information

• Brand Name: CARDINAL HEALTH
• Primary DI: 50885380158948
• Version / Model: CHB-GS-QC
• Catalog Number: CHB-GS-QC
• Company Name: CARDINAL HEALTH 200, LLC
• Labeler DUNS: 112164780
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 50
• Record Status: Published
• Publish Date: 2018-08-27
• Public Version: 2
• Public Version Date: 2018-09-27
• Public Version Status: Update
• Public Device Record Key: 9062f9cb-4b74-401d-b0d7-3022a3c54b50

Device Description

Control Slides for use with Single Slide Automate Gram Stainer

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: Yes
• 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
LJG	QUALITY CONTROL SLIDES	Microbiology	866.2660	1

GMDN Terms

Code	Name	Definition	Implantable	Status
43650	Gram stain IVD, control	A prepared slide and/or other associated material used to verify the performance of a Gram stain/staining kit (also referred to as Brown and Benn or Brown-Hopps stain) which is intended to be used for the demonstration and differentiation of bacteria in biological/clinical specimens.	No	Obsolete

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	50885380158948	GS1
Unit of Use	10885380158940	GS1

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 15 – 30 Degrees Celsius