CARDINAL HEALTH

Basic Information

• Brand Name: CARDINAL HEALTH
• Primary DI: 10195594497644
• Version / Model: SAN69BSWM6
• Catalog Number: SAN69BSWM6
• Company Name: Cardinal Health 200, LLC
• Labeler DUNS: 961027315
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2021-12-28
• Public Version: 1
• Public Version Date: 2022-01-05
• Public Version Status: New
• Public Device Record Key: e83837b5-67d8-4edc-b583-e39e84e7f26a

Device Description

RADIOLOGY 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	50195594497642	GS1	CASE	4	In Commercial Distribution
Primary	10195594497644	GS1

Storage Conditions

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