Playtex

Basic Information

• Brand Name: Playtex
• Primary DI: 00078300002161
• Version / Model: 00216
• Company Name: EDGEWELL PERSONAL CARE BRANDS, LLC
• Labeler DUNS: 151179769
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2019-02-15
• Public Version: 3
• Public Version Date: 2022-06-10
• Public Version Status: Update
• Public Device Record Key: d3ae3d12-bce1-4aef-b4c3-7bddbaaa1862

Device Description

Playtex Sport 16ct Reg Odorshield Scented

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: No
• MRI Safety: MR Safe
• Direct Marking Exempt: No
• PM Exempt: No
• 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
HIL	TAMPON, MENSTRUAL, SCENTED, DEODORIZED	Obstetrics/Gynecology	884.5460	2

GMDN Terms

Code	Name	Definition	Implantable	Status
32683	Menstrual tampon, scented	A deodorized plug made of cellulosic or synthetic material that is inserted into the vagina to absorb menstrual blood or other vaginal discharge. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	10078300002168	GS1		2	In Commercial Distribution
Package	20078300002165	GS1		6	In Commercial Distribution
Primary	00078300002161	GS1

Premarket Submissions

Submission Number	Supplement Number
K111684	000