Amazon Basics

Basic Information

• Brand Name: Amazon Basics
• Primary DI: 00195515003414
• Version / Model: BANDP32
• Company Name: AMAZON.COM SERVICES LLC
• Labeler DUNS: 128990418
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 32
• Record Status: Published
• Publish Date: 2021-10-31
• Public Version: 2
• Public Version Date: 2022-06-10
• Public Version Status: Update
• Public Device Record Key: 6002153f-3263-4839-b695-0c2bcf4f9e5e

Device Description

Amazon Basics Non Applicator tampons, Super Plus Absorbency, 32 count

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: 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: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
HEB	Tampon, Menstrual, Unscented	Obstetrics/Gynecology	884.5470	2

GMDN Terms

Code	Name	Definition	Implantable	Status
35694	Menstrual tampon, unscented	A non-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	10195515003411	GS1	CASE	12	In Commercial Distribution
Primary	00195515003414	GS1
Unit of Use	07290016625493	GS1

Premarket Submissions

Submission Number	Supplement Number
K965064	000

Device Sizes

Type	Value	Unit	Text
Device Size Text, specify			Absorbency