Inoue Balloon Catheter

GUDID 14960685200047

TORAY INDUSTRIES,INC.

Cardiac valvuloplasty catheter

• Primary Device ID: 14960685200047
• NIH Device Record Key: faf259ab-d13a-4840-9f28-5151721aa24d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Inoue Balloon Catheter
• Version Model Number: PTMC-28
• Company DUNS: 690535422
• Company Name: TORAY INDUSTRIES,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: true
• 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: true
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 2815872299
• Email: xxx@xxx.xxx
• Phone: 2815872299
• Email: xxx@xxx.xxx
• Phone: 2815872299
• Email: orders_med.tiam.mb@mail.toray
• Phone: 2815872299
• Email: orders_med.tiam.mb@mail.toray
• Phone: 2815872299
• Email: orders_med.tiam.mb@mail.toray
• Phone: 2815872299
• Email: orders_med.tiam.mb@mail.toray
• Phone: 2815872299
• Email: orders_med.tiam.mb@mail.toray
• Phone: 2815872299
• Email: orders_med.tiam.mb@mail.toray
• Phone: 2815872299
• Email: orders_med.tiam.mb@mail.toray
• Phone: 2815872299
• Email: orders_med.tiam.mb@mail.toray
• Phone: 2815872299
• Email: orders_med.tiam.mb@mail.toray
• Phone: 2815872299
• Email: orders_med.tiam.mb@mail.toray
• Phone: 2815872299
• Email: orders_med.tiam.mb@mail.toray
• Phone: 2815872299
• Email: orders_med.tiam.mb@mail.toray
• Phone: 2815872299
• Email: orders_med.tiam.mb@mail.toray
• Phone: 2815872299
• Email: orders_med.tiam.mb@mail.toray

Device Dimensions

• Device Size Text, specify: 0
• Catheter Gauge: 12 French
• Length: 70 Centimeter
• Device Size Text, specify: 0
• Catheter Gauge: 12 French
• Length: 70 Centimeter
• Device Size Text, specify: 0
• Catheter Gauge: 12 French
• Length: 70 Centimeter
• Device Size Text, specify: 0
• Catheter Gauge: 12 French
• Length: 70 Centimeter
• Device Size Text, specify: 0
• Catheter Gauge: 12 French
• Length: 70 Centimeter
• Device Size Text, specify: 0
• Catheter Gauge: 12 French
• Length: 70 Centimeter
• Device Size Text, specify: 0
• Catheter Gauge: 12 French
• Length: 70 Centimeter
• Device Size Text, specify: 0
• Catheter Gauge: 12 French
• Length: 70 Centimeter
• Device Size Text, specify: 0
• Catheter Gauge: 12 French
• Length: 70 Centimeter
• Device Size Text, specify: 0
• Catheter Gauge: 12 French
• Length: 70 Centimeter
• Device Size Text, specify: 0
• Catheter Gauge: 12 French
• Length: 70 Centimeter
• Device Size Text, specify: 0
• Catheter Gauge: 12 French
• Length: 70 Centimeter
• Device Size Text, specify: 0
• Catheter Gauge: 12 French
• Length: 70 Centimeter
• Device Size Text, specify: 0
• Catheter Gauge: 12 French
• Length: 70 Centimeter
• Device Size Text, specify: 0
• Catheter Gauge: 12 French
• Length: 70 Centimeter
• Device Size Text, specify: 0
• Catheter Gauge: 12 French
• Length: 70 Centimeter

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *The device should be stored at room temperature in a dark place.
• Special Storage Condition, Specify: Between 0 and 0 *The device should be stored at room temperature in a dark place.
• Special Storage Condition, Specify: Between 0 and 0 *The device should be stored at room temperature in a dark place.
• Special Storage Condition, Specify: Between 0 and 0 *The device should be stored at room temperature in a dark place.
• Special Storage Condition, Specify: Between 0 and 0 *The device should be stored at room temperature in a dark place.
• Special Storage Condition, Specify: Between 0 and 0 *The device should be stored at room temperature in a dark place.
• Special Storage Condition, Specify: Between 0 and 0 *The device should be stored at room temperature in a dark place.
• Special Storage Condition, Specify: Between 0 and 0 *The device should be stored at room temperature in a dark place.
• Special Storage Condition, Specify: Between 0 and 0 *The device should be stored at room temperature in a dark place.
• Special Storage Condition, Specify: Between 0 and 0 *The device should be stored at room temperature in a dark place.
• Special Storage Condition, Specify: Between 0 and 0 *The device should be stored at room temperature in a dark place.
• Special Storage Condition, Specify: Between 0 and 0 *The device should be stored at room temperature in a dark place.
• Special Storage Condition, Specify: Between 0 and 0 *The device should be stored at room temperature in a dark place.
• Special Storage Condition, Specify: Between 0 and 0 *The device should be stored at room temperature in a dark place.
• Special Storage Condition, Specify: Between 0 and 0 *The device should be stored at room temperature in a dark place.
• Special Storage Condition, Specify: Between 0 and 0 *The device should be stored at room temperature in a dark place.

Device Identifiers

Device Issuing Agency	Device ID
GS1	14960685200047 [Primary]

FDA Product Code

• MAD: Catheter, Percutaneous (Valvuloplasty)

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2018-03-29
• Device Publish Date: 2014-09-17

On-Brand Devices [Inoue Balloon Catheter]

• 14960685200054: PTMC-30
• 14960685200047: PTMC-28
• 14960685200030: PTMC-26