CVS HEALTH

Basic Information

• Brand Name: CVS HEALTH
• Primary DI: 00050428387443
• Version / Model: 715533-69755CV1
• Company Name: WOONSOCKET PRESCRIPTION CENTER, INCORPORATED
• Labeler DUNS: 062312574
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2020-07-29
• Public Version: 2
• Public Version Date: 2021-05-10
• Public Version Status: Update
• Public Device Record Key: 74d08329-9ad0-46d8-9253-48fe264fd9f1

Device Description

MEDICAL LIGHT & SCOPE

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• Over the Counter (OTC): Yes
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: Yes
• 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
FXF	Speculum, Illuminated	General, Plastic Surgery	878.1800	1

GMDN Terms

Code	Name	Definition	Implantable	Status
12849	Otoscope, direct	An electrically-powered, hand-held device designed for examination of the outer ear canal and tympanic membrane (eardrum) by direct viewing through the ear opening. It consists of a main unit (commonly referred to as the head) with a built-in light source intended to illuminate the interior of the ear canal with a detachable cone-shaped tube (speculum) inserted in the ear canal; it may facilitate the application of air pressure for pneumatic otoscopy. A dedicated power supply handpiece and/or an insufflation bulb may be included with the head.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	10050428387440	GS1	CASE	24	In Commercial Distribution
Primary	00050428387443	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]