BLUME

GUDID 00628504315088

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

ELLEBOX

Menstrual tampon, unscented

• Primary Device ID: 00628504315088
• NIH Device Record Key: 394279fb-abaf-4bc8-a01d-c0a9ca9d3917
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: BLUME
• Version Model Number: Regular & Super Tampons
• Company DUNS: 076616985
• Company Name: ELLEBOX
• Device Count: 16
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: true

Device Identifiers

Device Issuing Agency	Device ID
GS1	00628504315088 [Primary]
GS1	10628504315085 [Unit of Use]
GS1	30628504315089 [Package]; Package: [12 Units]; In Commercial Distribution

FDA Product Code

• HEB: Tampon, Menstrual, Unscented

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2019-11-22
• Device Publish Date: 2019-08-09

On-Brand Devices [BLUME]

• 00628504315088: The box contains two types of tampons (8+8) offered in two adsorbencies: Regular and Super. Each
• 00628504315057: Super Tampons
• 00628504315033: Regular Tampons