AccessGUDID - DEVICE: NES Reprocessed Visions PV .035 Digital IVUS Catheter (R88901)

GUDID

Device Identifier (DI) Information

Brand Name: NES Reprocessed Visions PV .035 Digital IVUS Catheter
Version or Model: R-88901
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: R-88901
Company Name: NORTH EAST SCIENTIFIC INC

Primary DI Number: R88901
Issuing Agency: HIBCC
Commercial Distribution End Date: July 12, 2023
Device Count: 1
Labeler D-U-N-S® Number*: 608625823 *Terms of Use

Device Description: The device is the Philips Vision PV .035 Digital IVUS catheter that is reprocessed by Northeast Scientific, Inc. (NES).

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:	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 [?]
K181126	000

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
Catheter Working Length: 90 Centimeter
Lumen/Inner Diameter: .035 Inch

Device Record Status

Public Device Record Key: 7ae4240a-cef4-4783-91df-a45ceabac990
Public Version Date: July 13, 2023
Public Version Number: 3
DI Record Publish Date: March 21, 2019