VeinViewer 3.0 Flex 134-002102-02

GUDID M870134002102021

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 .

Christie Medical Holdings, Inc.

Hand-held multi-spectral vascular imaging device Hand-held multi-spectral vascular imaging device Hand-held multi-spectral vascular imaging device Hand-held multi-spectral vascular imaging device Hand-held multi-spectral vascular imaging device Hand-held multi-spectral vascular imaging device Hand-held multi-spectral vascular imaging device Hand-held multi-spectral vascular imaging device Hand-held multi-spectral vascular imaging device Hand-held multi-spectral vascular imaging device Hand-held multi-spectral vascular imaging device Hand-held multi-spectral vascular imaging device Hand-held multi-spectral vascular imaging device Hand-held multi-spectral vascular imaging device Hand-held multi-spectral vascular imaging device Hand-held multi-spectral vascular imaging device

• Primary Device ID: M870134002102021
• NIH Device Record Key: 41ea4066-e943-46c7-ae7c-44059ed1d2ba
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: VeinViewer 3.0 Flex
• Version Model Number: 3.0 Flex
• Catalog Number: 134-002102-02
• Company DUNS: 117398857
• Company Name: Christie Medical Holdings, Inc.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Operating and Storage Conditions

• Handling Environment Temperature: Between -10 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Handling Environment Humidity: Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -10 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Handling Environment Humidity: Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -10 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Handling Environment Humidity: Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -10 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Handling Environment Humidity: Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -10 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Handling Environment Humidity: Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -10 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Handling Environment Humidity: Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -10 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Handling Environment Humidity: Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -10 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Handling Environment Humidity: Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -10 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Handling Environment Humidity: Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -10 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Handling Environment Humidity: Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -10 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Handling Environment Humidity: Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -10 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Handling Environment Humidity: Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -10 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Handling Environment Humidity: Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -10 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Handling Environment Humidity: Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -10 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Handling Environment Humidity: Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -10 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Handling Environment Humidity: Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	M870134002102021 [Primary]

FDA Product Code

• KZA: Device, Vein Location, Liquid Crystal

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-09-22
• Device Publish Date: 2022-09-14