Harmony Polyisoprene Dams Bulk Box

Basic Information

• Brand Name: Harmony Polyisoprene Dams Bulk Box
• Primary DI: 00860003804506
• Version / Model: HA-101
• Company Name: Pamco Distributing Inc
• Labeler DUNS: 208394130
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 60
• Record Status: Published
• Publish Date: 2022-02-17
• Public Version: 1
• Public Version Date: 2022-02-25
• Public Version Status: New
• Public Device Record Key: 7b6f4899-8940-40c6-b322-b5261f431b91

Device Description

Harmony Polyisoprene Dams Bulk Box of 60.

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: Yes
• 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
MSC	Barrier, Std, Oral Sex	Obstetrics/Gynecology	884.5300	2

GMDN Terms

Code	Name	Definition	Implantable	Status
47722	Female condom, synthetic polymer	A sheath made of synthetic polymers (e.g., polyurethane or nitrile) with rings on either end that is inserted into the vagina before coitus to prevent sperm from gaining access to the female reproductive tract and/or to prevent the transmission of sexually transmitted infections (STI) between sexual partners. It typically includes a lubricant to minimize friction during coitus. 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	00860003804544	GS1
Primary	00860003804506	GS1

Premarket Submissions

Submission Number	Supplement Number
K203727	000