Catalog Number

-

Brand Name

BLUME

Version/Model Number

Regular & Super Tampons

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

Labeling does not contain MRI Safety Information

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

-

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

Yes

Prescription Use (Rx)

-

Over the Counter (OTC)

Yes

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code

HEB

Product Code Name

Tampon, Menstrual, Unscented

Public Device Record Key

394279fb-abaf-4bc8-a01d-c0a9ca9d3917

Public Version Date

June 10, 2022

Public Version Number

3

DI Record Publish Date

August 09, 2019

Package DI Number

30628504315089

Quantity per Package

12

Contains DI Package

00628504315088

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-