AccessGUDID - DEVICE: Unetixs Vascular (B4371198605)

GUDID

Device Identifier (DI) Information

Brand Name: Unetixs Vascular
Version or Model: Multilab Series 2 LHS Roodra
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 11986-0000-01
Company Name: UNETIXS VASCULAR, INC.

Primary DI Number: B4371198605
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 625463146 *Terms of Use

Device Description: The MultiLab is intended for use as a non-invasive diagnostic device by trained medical personnel following physician orders. This device is intended for the detection of obstruction to blood flow in human arteries and veins as an aid for the diagnosis of disease in the peripheral vascular system.

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?
13056	Limb plethysmograph	A graphic recorder designed for determining and registering volume variations in the extremities (legs/toes and/or arms/fingers) as modified by the circulation of blood through them. It typically consists of flow and/or volume sensors and transducers attached to an electronic unit, which processes the data and displays the results. It may operate using one of several methods including venous occlusion (pneumatic), photoelectric, electrical impedance, or strain gauge. The device is typically used in peripheral vascular diagnostic investigations [e.g., for deep vein thrombosis (DVT) or arterial occlusive disease].	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
JAF	Monitor, Ultrasonic, Nonfetal

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K904392	000

Device Exempt from Premarket Submission: No 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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 1ac7c85d-abd5-40e1-84f1-e82e654346ad
Public Version Date: March 07, 2023
Public Version Number: 1
DI Record Publish Date: February 27, 2023