Marina Medical

Basic Information

• Brand Name: Marina Medical
• Primary DI: 00840306833540
• Version / Model: BFS4000
• Catalog Number: BFS4000
• Company Name: MARINA MEDICAL INSTRUMENTS, INC.
• Labeler DUNS: 011442279
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2024-08-30
• Public Version: 1
• Public Version Date: 2024-09-09
• Public Version Status: New
• Public Device Record Key: dc0a7c7d-90ca-43a7-a995-9994bf138cde

Device Description

Pessary “Oval” Fitting Kit

Device Characteristics

• Single Use: No
• 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: Yes
• 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: Yes
• Sterilization Methods: Moist Heat or Steam Sterilization

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
HHW	PESSARY, VAGINAL	Obstetrics/Gynecology	884.3575	2

GMDN Terms

Code	Name	Definition	Implantable	Status
34149	Pelvic-organ-supporting pessary	A device made of rubber or soft plastics designed for insertion into the vagina to hold the uterus, bladder and/or rectum in place and help prevent prolapse (falling or sliding of the organ from its normal position into the pelvic cavity), either as a permanent or temporary treatment; it is not dedicated to bladder-only support. It is available in a variety of shapes (e.g., rings, stems) and sizes; it may be fitted for each woman individually. This is a reusable device after appropriate cleaning.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00840306833540	GS1

Customer Contacts

• Phone: [phone] ext. 115
• Email: [email protected]