BEUDAMED

FDA UDI Not in Commercial Distribution 🇺🇸 United States

Neutrogena

DI: 00070501101261 · Model: 00070501101261 · Kenvue Brands LLC

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Product Codes

1

GMDN Terms

1

Identifiers

1

Pkg Device Count

1

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Basic Information

Brand Name: Neutrogena
Primary DI: 00070501101261
Version / Model: 00070501101261
Company Name: Kenvue Brands LLC
Labeler DUNS: 118772437
Distribution Status: Not in Commercial Distribution
Device Count in Pkg: 1
Record Status: Published
Publish Date: 2016-09-30
Public Version: 6
Public Version Date: 2024-11-04
Public Version Status: Update
Public Device Record Key: a7f92b84-1ccf-4a73-8cb8-6aa0585f6d39
Distribution End Date: 2020-06-22

Device Description

Light Therapy Acne Mask Activator

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: No
PM Exempt: No
Has Serial Number: No
Has Lot/Batch Number: Yes
Has Manufacturing Date: No
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
OLP	Over-the-counter powered light based laser for acne	General, Plastic Surgery	878.4810	2

GMDN Terms

Code	Name	Definition	Implantable	Status
62116	Red/blue light phototherapy unit	A portable electrically-powered device intended to emit both red and blue light for the treatment of a facial skin condition (e.g., acne, hyperpigmentation) by the patient in the home. It includes integral lights with a controller/controlling interface (to pair with an off-the-shelf computer/smartphone), and may be available in a variety of forms (e.g., a face-worn light mask with controller, hand-held light unit). It is not intended for use with a photosensitizing agent. This is a single-patient, reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00070501101261	GS1

Customer Contacts

Phone: +1(800)361-8068
Email: [email protected]

Storage Conditions

Type: Storage Environment Atmospheric Pressure
Temperature Range: .7 – 1.06 KiloPascal
Type: Storage Environment Humidity
Temperature Range: 0 – 60 Percent (%) Relative Humidity
Type: Storage Environment Temperature
Temperature Range: 5 – 25 Degrees Celsius