CARDINAL HEALTH

Basic Information

• Brand Name: CARDINAL HEALTH
• Primary DI: 20885380144889
• Version / Model: CHB900812
• Catalog Number: CHB900812
• Company Name: Cardinal Health 200, LLC
• Labeler DUNS: 961027315
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 20
• Record Status: Published
• Publish Date: 2019-06-28
• Public Version: 3
• Public Version Date: 2021-11-25
• Public Version Status: Update
• Public Device Record Key: e9d46f9b-f6fe-416a-bc00-a5684d17033c

Device Description

Enteric Stool Transport Vial

Device Characteristics

• Single Use: Yes
• 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
JSM	CULTURE MEDIA, NON-PROPAGATING TRANSPORT	Microbiology	866.2390	1

GMDN Terms

Code	Name	Definition	Implantable	Status
57911	Faecal specimen container IVD, transport buffer/medium	A covered receptacle containing transport buffer solution or microbiological medium (e.g., Carey-Blair transport medium) intended to be used for the collection, preservation, and transport of a faecal specimen for in vitro diagnostic investigation. It does not contain patient-contact specimen sampling/extraction devices such as swabs/brushes. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	50885380144880	GS1	CASE	6	In Commercial Distribution
Primary	20885380144889	GS1
Unit of Use	10885380144882	GS1

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 2 – 30 Degrees Celsius