VeinViewer 3.0 Flex

Basic Information

• Brand Name: VeinViewer 3.0 Flex
• Primary DI: M870134002102021
• Version / Model: 3.0 Flex
• Catalog Number: 134-002102-02
• 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: 41ea4066-e943-46c7-ae7c-44059ed1d2ba

Device Description

VeinViewer Flex is designed for ease of use. VeinViewer Flex utilizes visible and near-infrared light for vascular imaging to illuminate and project the subcutaneous venous structure directly onto a patient’s skin. AVIN™ (Active Vascular Imaging Navigation) allows the user to assess multiple access points with a re al-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
58815	Hand-held multi-spectral vascular imaging device	A battery-powered, hand-held 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 an optical unit for non-laser imaging which allows the operator to assess multiple vascular access points with a real-time digital image [active vascular imaging navigation (AVIN)] on any part of the anatomy. The device includes rechargeable batteries that allow its operation for a limited period. It is used in a variety of clinical settings. This portable device can also be attached to static mounting arm.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	M870134002102021	HIBCC

Storage Conditions

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