CARDINAL HEALTH

Basic Information

• Brand Name: CARDINAL HEALTH
• Primary DI: 20885380185608
• Version / Model: CHB13904P
• Catalog Number: CHB13904P
• Company Name: Cardinal Health 200, LLC
• Labeler DUNS: 961027315
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 75
• Record Status: Published
• Publish Date: 2023-05-30
• Public Version: 2
• Public Version Date: 2023-11-03
• Public Version Status: Update
• Public Device Record Key: 4b9e8331-22f6-4b89-aef9-6cf745ef6033

Device Description

Specimen Container

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: No
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
FMH	CONTAINER, SPECIMEN, STERILE	Pathology	864.3250	1

GMDN Terms

Code	Name	Definition	Implantable	Status
46237	General laboratory container, single-use	A container (e.g., test tube, bottle, cup, assay tray with large wells) intended to be used as a non-dedicated receptacle to hold consumable laboratory substances (e.g., reagents, buffers), specimens, and other materials associated with procedures in the laboratory; it is not intended for in vitro diagnostic procedures. It is typically made of plastic or glass and may be used on the benchtop for manual procedures, or on-board automated liquid handling instruments or analysers. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	50885380185609	GS1	CASE	4	In Commercial Distribution
Primary	20885380185608	GS1
Unit of Use	10885380185601	GS1