BLUME

Basic Information

• Brand Name: BLUME
• Primary DI: 00628504315088
• Version / Model: Regular & Super Tampons
• Company Name: ELLEBOX
• Labeler DUNS: 076616985
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 16
• Record Status: Published
• Publish Date: 2019-08-09
• Public Version: 3
• Public Version Date: 2022-06-10
• Public Version Status: Update
• Public Device Record Key: 394279fb-abaf-4bc8-a01d-c0a9ca9d3917

Device Description

The box contains two types of tampons (8+8) offered in two adsorbencies: Regular and Super. Each tampon is registered in GUDID database with a different Primary DI Number: - Regular Tampons: 00628504315033 - Super Tampons: 00628504315057

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
Primary	00628504315088	GS1
Unit of Use	10628504315085	GS1
Package	30628504315089	GS1		12	In Commercial Distribution