CARDINAL HEALTH

Basic Information

• Brand Name: CARDINAL HEALTH
• Primary DI: 20885380021111
• Version / Model: C1565-004
• Catalog Number: C1565-004
• Company Name: Cardinal Health 200, LLC
• Labeler DUNS: 961027315
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 500
• Record Status: Published
• Publish Date: 2019-01-02
• Public Version: 2
• Public Version Date: 2019-05-17
• Public Version Status: Update
• Public Device Record Key: 21df2ba5-2fc4-46e1-93e2-927ba84b891e

Device Description

Tongue Blades, 5 1/2in. L

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: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
FMA	DEPRESSOR, TONGUE, NON-SURGICAL	General Hospital	880.6230	1

GMDN Terms

Code	Name	Definition	Implantable	Status
42461	Tongue depressor, examination, single-use	A hand-held device used to displace the tongue to facilitate examination of the surrounding organs/tissues. It is typically a double-ended flat device with rounded working ends made of wood or plastic materials; it may be aromatic/flavoured to make then less intrusive. The device may be used in a healthcare facility, doctor's office, or in the home. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	20885380021111	GS1
Unit of Use	10885380021114	GS1
Package	50885380021112	GS1	CASE	10	In Commercial Distribution