Meridian VPS

Basic Information

• Brand Name: Meridian VPS
• Primary DI: 05708932553759
• Version / Model: 52080
• Catalog Number: 52080
• Company Name: Coloplast A/S
• Labeler DUNS: 305524696
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-09-22
• Public Version: 1
• Public Version Date: 2023-10-02
• Public Version Status: New
• Public Device Record Key: dae42019-d974-4a49-9dec-2bb09121f928

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• 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: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
LKF	Cannula, manipulator/injector, uterine	Obstetrics/Gynecology	884.4530	2
PWK	Instrumentation, surgical mesh, urogynecologic, transabdominal repair of pelvic organ prolapse	Obstetrics/Gynecology	884.4910	2

GMDN Terms

Code	Name	Definition	Implantable	Status
37468	Vaginal speculum, single-use	A hand-held manual instrument intended to dilate the vagina after insertion, typically for visual examination of the vaginal canal and cervix and/or to perform a gynaecological procedure. It typically consists of two long blades, joined at a handle at one end, that are inserted into the vagina in a horizontal position and then opened to form an angle, or it is a soft-material device inflated after insertion that allows viewing and access through a central channel. It is typically made entirely of plastic materials or has removable blades made of plastic. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	05708932553759	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K173501	000

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: Keep away from sunlight. Do not use if package is damaged and consult IFU. Do not resterilize.