BIOPURE

Basic Information

• Brand Name: BIOPURE
• Primary DI: 10198926000338
• Version / Model: BP2704-1PK
• Company Name: Quest USA Corp.
• Labeler DUNS: 079869689
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 36
• Record Status: Published
• Publish Date: 2025-03-01
• Public Version: 1
• Public Version Date: 2025-03-10
• Public Version Status: New
• Public Device Record Key: 71947d59-02b8-485f-ac36-2135433ad96d

Device Description

TAMPONS SUPER -36CT

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• 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: Yes
• 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
Unit of Use	00198926004421	GS1
Primary	10198926000338	GS1
Package	10198926000369	GS1	polybag	3	In Commercial Distribution