CARDINAL HEALTH

Basic Information

• Brand Name: CARDINAL HEALTH
• Primary DI: 10197106513279
• Version / Model: AMN410130B
• Catalog Number: AMN410130B
• Company Name: Cardinal Health 200, LLC
• Labeler DUNS: 961027315
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2024-01-23
• Public Version: 1
• Public Version Date: 2024-01-31
• Public Version Status: New
• Public Device Record Key: 7ae65e7d-d8b1-4301-b031-9a3d8d4204a5

Device Description

KIT, ER COMFORT

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: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
LRA	Hearing aid, tactile	Unknown		U

GMDN Terms

Code	Name	Definition	Implantable	Status
44011	Decontamination floor mat, single-use	A pad made of coarse, durable material that is designed to be placed on the floor to wipe the soles of the footwear of persons walking on its surface. The product is intended to reduce the distribution of dirt/contaminated materials on the floor. The product is for single-use and is not washed or cleaned for reuse. It may be a pad of layered adhesive sheets that bind dirt touching the surface; when the sheet is sufficiently saturated it is peeled off and discarded to reveal a new adhesive surface.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	50197106513277	GS1	CASE	38	In Commercial Distribution
Primary	10197106513279	GS1

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: High: 40 Degrees Celsius