CARDINAL HEALTH

Basic Information

• Brand Name: CARDINAL HEALTH
• Primary DI: 10197106390535
• Version / Model: SAN34BAB11
• Catalog Number: SAN34BAB11
• Company Name: Cardinal Health 200, LLC
• Labeler DUNS: 961027315
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-07-25
• Public Version: 1
• Public Version Date: 2023-08-02
• Public Version Status: New
• Public Device Record Key: 7a830e3c-3e2e-4f4d-bdaf-2ef1a21bfeba

Device Description

BARS ARTHROGRAM PACK

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: Yes
• 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: Yes
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
OIP	Radiology-diagnostic kit	Radiology	892.1680	2

GMDN Terms

Code	Name	Definition	Implantable	Status
15316	Arthrogram kit	A collection of instruments, pharmaceuticals, equipment and various supplies intended to be used to visualize a joint by radiographic study after injection of a contrast medium into the joint space. This is a reusable device after the appropriate cleaning/sterilization of the instruments/reusable products and the consumable/pharmaceutical products have been replenished.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	50197106390533	GS1	CASE	28	In Commercial Distribution
Primary	10197106390535	GS1

Storage Conditions

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