CryoPlasty

GUDID B479PCIU5000000

CryoPlasty inflation unit for use with PolarCath peripheral dilation system

Nucryo Vascular

Peripheral angioplasty balloon catheter, basic

• Primary Device ID: B479PCIU5000000
• NIH Device Record Key: 5e566ee7-290e-48a8-8b41-fc3c6f7fdee3
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CryoPlasty
• Version Model Number: PCIU500000
• Company DUNS: 045796615
• Company Name: Nucryo Vascular
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: true
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B479PCIU5000000 [Primary]

FDA Product Code

• DQY: Catheter, Percutaneous

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2018-04-19
• Device Publish Date: 2018-03-19

Devices Manufactured by Nucryo Vascular

• B479NC30000010 - PolarCath: 2018-04-19 PolarCath nitrous oxide cartridge for use with PolarCath peripheral dilation system
• B479P4100120010 - PolarCath: 2018-04-19 PolarCath peripheral dilation catheter over the wire 6F . (4.0mm x 100mm, 120cm)
• B479P4150120010 - PolarCath: 2018-04-19 PolarCath peripheral dilation catheter over the wire 6F . ( 4.0mm x 150mm, 120cm)
• B479P440120010 - PolarCath: 2018-04-19 PolarCath peripheral dilation catheter over the wire 6F ( 4.0mm x 40mm, 120cm)
• B479P5100120010 - PolarCath: 2018-04-19 PolarCath peripheral dilation catheter over the wire 6F . ( 5.0mm x 100mm, 120cm)
• B479P5150120010 - PolarCath: 2018-04-19 PolarCath peripheral dilation catheter over the wire 6F . ( 5.0mm x 150mm, 120cm)
• B479P540120010 - PolarCath: 2018-04-19 PolarCath peripheral dilation catheter over the wire 6F . ( 5.0mm x 40mm, 120cm)
• B479P6100120010 - PolarCath: 2018-04-19 PolarCath peripheral dilation catheter over the wire 7F. ( 6.0mm x 100mm, 120cm)