HERizon Medical Endoscope Image Processor

Basic Information

• Brand Name: HERizon Medical Endoscope Image Processor
• Primary DI: 00850033976250
• Version / Model: JY-MIP-1000
• Catalog Number: JY-MIP-1000
• Company Name: Minerva Surgical, Inc.
• Labeler DUNS: 829616478
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2024-10-07
• Public Version: 1
• Public Version Date: 2024-10-15
• Public Version Status: New
• Public Device Record Key: 442240d3-3413-47bc-a010-05a2d6fd2301

Device Description

Medical Endoscope Image Processor For Use with HERizon Disposable Electronic Hysteroscope.

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: Yes
• Has Lot/Batch Number: No
• 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
HIH	Hysteroscope (And Accessories)	Obstetrics/Gynecology	884.1690	2

GMDN Terms

Code	Name	Definition	Implantable	Status
18034	Endoscopic video image processing unit	An electrically-powered device designed to receive and process the electronic signals sent from a video endoscope or endoscopic video camera; it does not include the endoscope nor light source and is not designed to control the endoscope. It may have additional features which compensate for/enhance the colour and light qualities provided. The resulting picture images are sent to and shown on a visual display unit (VDU), typically to assist the endoscope operator with an ongoing intervention and often to allow the patient visualization of the process; the images can be recorded on a video recorder or stored on computerized media.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00850033976250	GS1

Customer Contacts

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

Storage Conditions

• Type: Storage Environment Atmospheric Pressure
• Temperature Range: 700 – 1060 Millimeter of Mercury
• Type: Storage Environment Humidity
• Temperature Range: 30 – 75 Percent (%) Relative Humidity
• Type: Storage Environment Temperature
• Temperature Range: -10 – 45 Degrees Celsius