Mespere

Basic Information

• Brand Name: Mespere
• Primary DI: M9833340000101
• Version / Model: RH-01
• Company Name: Mespere LifeSciences Inc
• Labeler DUNS: 203147665
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-10-06
• Public Version: 4
• Public Version Date: 2020-05-06
• Public Version Status: Update
• Public Device Record Key: 9d449f56-b2ad-4766-8c94-ebbba20f06eb

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: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
PFA	Non-Invasive Central Venous Manometer	Cardiovascular	870.1140	2

GMDN Terms

Code	Name	Definition	Implantable	Status
34931	Venous pressure monitor, invasive detection	An electrically-powered device designed for continuous or intermittent measurement, display, and recording of a patient's direct central or peripheral venous pressure, or the difference between central and peripheral venous pressure, by means of an indwelling catheter and a pressure manometer.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	M9833340000101	HIBCC

Premarket Submissions

Submission Number	Supplement Number
K151776	000