AccessGUDID - DEVICE: Vein360 Reprocessed Visions PV.014P RX Digitial IVUS Catheter (014P) (00860036000579)

GUDID

Device Identifier (DI) Information

Brand Name: Vein360 Reprocessed Visions PV.014P RX Digitial IVUS Catheter (014P)
Version or Model: VEN-PV-014P
Commercial Distribution Status: In Commercial Distribution
Catalog Number: VEN-PV-014P
Company Name: Vein360 LLC

Primary DI Number: 00860036000579
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 080926907 *Terms of Use

Device Description: Vein360 Reprocessed Visions PV.014P RX Digitial IVUS Catheter (014P)

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":	Yes
For Single-Use:	Yes
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?
64174	Intravascular ultrasound imaging catheter, reprocessed	A flexible, non-steerable tube with an ultrasound imaging transducer enclosed in a fluid-resistant or waterproof acoustically- and electrically-insulated housing, designed for insertion into the vascular system (i.e., peripheral vascular system, coronary artery) by an operator; it is not intended for intracardial insertion/imaging. Also known as a vascular ultrasound transducer, it includes a single or an array of transducer element(s). This is a previously used single-use device that has been processed for an additional single-use patient application.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
OWQ	Reprocessed Intravascular Ultrasound Catheter

FDA Premarket Submission

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

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: Yes
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: a348c1de-901b-469a-ab9f-4436dc76578b
Public Version Date: April 02, 2024
Public Version Number: 1
DI Record Publish Date: March 25, 2024