NES Reprocessed Visions PV .014P RX Digital IVUS Catheter R-014R

GUDID B227NRP0140

NORTH EAST SCIENTIFIC INC

Intravascular ultrasound imaging catheter, reprocessed

• Primary Device ID: B227NRP0140
• NIH Device Record Key: a04b9ea7-3997-47cd-b93c-55a7d81094b4
• Commercial Distribution Discontinuation: 2030-11-24
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: NES Reprocessed Visions PV .014P RX Digital IVUS Catheter
• Version Model Number: R-014R
• Catalog Number: R-014R
• Company DUNS: 608625823
• Company Name: NORTH EAST SCIENTIFIC INC
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 203-756-2111
• Email: matt@smarthealth-care.com
• Phone: 203-756-2111
• Email: matt@smarthealth-care.com
• Phone: 203-756-2111
• Email: matt@smarthealth-care.com
• Phone: 203-756-2111
• Email: matt@smarthealth-care.com
• Phone: 203-756-2111
• Email: matt@smarthealth-care.com
• Phone: 203-756-2111
• Email: matt@smarthealth-care.com
• Phone: 203-756-2111
• Email: matt@smarthealth-care.com
• Phone: 203-756-2111
• Email: matt@smarthealth-care.com
• Phone: 203-756-2111
• Email: matt@smarthealth-care.com
• Phone: 203-756-2111
• Email: matt@smarthealth-care.com
• Phone: 203-756-2111
• Email: matt@smarthealth-care.com
• Phone: 203-756-2111
• Email: matt@smarthealth-care.com
• Phone: 203-756-2111
• Email: matt@smarthealth-care.com
• Phone: 203-756-2111
• Email: matt@smarthealth-care.com
• Phone: 203-756-2111
• Email: matt@smarthealth-care.com
• Phone: 203-756-2111
• Email: matt@smarthealth-care.com
• Phone: 203-756-2111
• Email: matt@smarthealth-care.com
• Phone: 203-756-2111
• Email: matt@smarthealth-care.com

Device Dimensions

• Catheter Working Length: 150 Centimeter
• Catheter Gauge: 3.5 French
• Lumen/Inner Diameter: 0.014 Inch
• Catheter Working Length: 150 Centimeter
• Catheter Gauge: 3.5 French
• Lumen/Inner Diameter: 0.014 Inch
• Catheter Working Length: 150 Centimeter
• Catheter Gauge: 3.5 French
• Lumen/Inner Diameter: 0.014 Inch
• Catheter Working Length: 150 Centimeter
• Catheter Gauge: 3.5 French
• Lumen/Inner Diameter: 0.014 Inch
• Catheter Working Length: 150 Centimeter
• Catheter Gauge: 3.5 French
• Lumen/Inner Diameter: 0.014 Inch
• Catheter Working Length: 150 Centimeter
• Catheter Gauge: 3.5 French
• Lumen/Inner Diameter: 0.014 Inch
• Catheter Working Length: 150 Centimeter
• Catheter Gauge: 3.5 French
• Lumen/Inner Diameter: 0.014 Inch
• Catheter Working Length: 150 Centimeter
• Catheter Gauge: 3.5 French
• Lumen/Inner Diameter: 0.014 Inch
• Catheter Working Length: 150 Centimeter
• Catheter Gauge: 3.5 French
• Lumen/Inner Diameter: 0.014 Inch
• Catheter Working Length: 150 Centimeter
• Catheter Gauge: 3.5 French
• Lumen/Inner Diameter: 0.014 Inch
• Catheter Working Length: 150 Centimeter
• Catheter Gauge: 3.5 French
• Lumen/Inner Diameter: 0.014 Inch
• Catheter Working Length: 150 Centimeter
• Catheter Gauge: 3.5 French
• Lumen/Inner Diameter: 0.014 Inch
• Catheter Working Length: 150 Centimeter
• Catheter Gauge: 3.5 French
• Lumen/Inner Diameter: 0.014 Inch
• Catheter Working Length: 150 Centimeter
• Catheter Gauge: 3.5 French
• Lumen/Inner Diameter: 0.014 Inch
• Catheter Working Length: 150 Centimeter
• Catheter Gauge: 3.5 French
• Lumen/Inner Diameter: 0.014 Inch
• Catheter Working Length: 150 Centimeter
• Catheter Gauge: 3.5 French
• Lumen/Inner Diameter: 0.014 Inch
• Catheter Working Length: 150 Centimeter
• Catheter Gauge: 3.5 French
• Lumen/Inner Diameter: 0.014 Inch
• Catheter Working Length: 150 Centimeter
• Catheter Gauge: 3.5 French
• Lumen/Inner Diameter: 0.014 Inch

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B227NRP0140 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K200195

FDA Product Code

• OBJ: Catheter, Ultrasound, Intravascular

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-07-20
• Device Publish Date: 2023-07-12

On-Brand Devices [NES Reprocessed Visions PV .014P RX Digital IVUS Catheter]

• NRP014: The device is the Philips Vision PV .014P RX Digital IVUS catheter that is reprocessed by Northe
• B227NRP0140: R-014R