AccessGUDID - DEVICE: VeinViewer 4.0 Vision2 (M870134003104011)

GUDID

Device Identifier (DI) Information

Brand Name: VeinViewer 4.0 Vision2
Version or Model: 4.0 Vision2
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 134-003104-01
Company Name: Christie Medical Holdings, Inc.

Primary DI Number: M870134003104011
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 117398857 *Terms of Use

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

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
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.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
KZA	Device, Vein Location, Liquid Crystal

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: Yes CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

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

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: e7fc693d-a4d2-4880-9f4c-371841690ade
Public Version Date: September 22, 2022
Public Version Number: 1
DI Record Publish Date: September 14, 2022