VeinViewer 4.0 Vision2

Basic Information

• Brand Name: VeinViewer 4.0 Vision2
• Primary DI: M870134003104011
• Version / Model: 4.0 Vision2
• Catalog Number: 134-003104-01
• Company Name: Christie Medical Holdings, Inc.
• Labeler DUNS: 117398857
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-09-14
• Public Version: 1
• Public Version Date: 2022-09-22
• Public Version Status: New
• Public Device Record Key: e7fc693d-a4d2-4880-9f4c-371841690ade

Device Description

VeinViewer Vision2 uses visible and near infrared light to illuminate and project the subcutaneous venous structure directly onto the skin of a patient with a real-time digital image.

Device Characteristics

• Single Use: No
• 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: Yes
• 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
KZA	Device, Vein Location, Liquid Crystal	General Hospital	880.6970	1

GMDN Terms

Code	Name	Definition	Implantable	Status
58123	Mobile multi-spectral vascular imaging device	A mains electricity (AC-powered) mobile (on wheels) device designed to utilize visible and near infrared (IR) light for superficial vascular structure imaging by illuminating and projecting the subcutaneous venous structure of a patient onto the patient's skin surface. The device includes controls and a head unit for non-laser imaging; the adjustable head is intended to allow the operator to hands-free assess multiple vascular access points with a real-time digital image [active vascular imaging navigation (AVIN)] on any part of the anatomy. The device may include rechargeable batteries that allow its operation for a limited period without line power.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	M870134003104011	HIBCC

Storage Conditions

• Type: Handling Environment Temperature
• Temperature Range: -10 – 140 Degrees Fahrenheit
• Type: Handling Environment Humidity
• Temperature Range: 0 – 90 Percent (%) Relative Humidity