INOUE BALLOON A

GUDID 14960685201396

TORAY INDUSTRIES,INC.

Cardiac valvuloplasty catheter Cardiac valvuloplasty catheter Cardiac valvuloplasty catheter Cardiac valvuloplasty catheter Cardiac valvuloplasty catheter Cardiac valvuloplasty catheter Cardiac valvuloplasty catheter Cardiac valvuloplasty catheter Cardiac valvuloplasty catheter Cardiac valvuloplasty catheter Cardiac valvuloplasty catheter Cardiac valvuloplasty catheter Cardiac valvuloplasty catheter Cardiac valvuloplasty catheter Cardiac valvuloplasty catheter Cardiac valvuloplasty catheter Cardiac valvuloplasty catheter

• Primary Device ID: 14960685201396
• NIH Device Record Key: 72ff0afd-5c6d-4a0a-aba0-557b757ae5c6
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: INOUE BALLOON A
• Version Model Number: PTAV-18RP
• 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: true
• OTC Over-The-Counter: false

Customer Support Contacts

• 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
• 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

• Length: 105 Centimeter
• Catheter Gauge: 10 French
• Device Size Text, specify: 0
• Length: 105 Centimeter
• Catheter Gauge: 10 French
• Device Size Text, specify: 0
• Length: 105 Centimeter
• Catheter Gauge: 10 French
• Device Size Text, specify: 0
• Length: 105 Centimeter
• Catheter Gauge: 10 French
• Device Size Text, specify: 0
• Length: 105 Centimeter
• Catheter Gauge: 10 French
• Device Size Text, specify: 0
• Length: 105 Centimeter
• Catheter Gauge: 10 French
• Device Size Text, specify: 0
• Length: 105 Centimeter
• Catheter Gauge: 10 French
• Device Size Text, specify: 0
• Length: 105 Centimeter
• Catheter Gauge: 10 French
• Device Size Text, specify: 0
• Length: 105 Centimeter
• Catheter Gauge: 10 French
• Device Size Text, specify: 0
• Length: 105 Centimeter
• Catheter Gauge: 10 French
• Device Size Text, specify: 0
• Length: 105 Centimeter
• Catheter Gauge: 10 French
• Device Size Text, specify: 0
• Length: 105 Centimeter
• Catheter Gauge: 10 French
• Device Size Text, specify: 0
• Length: 105 Centimeter
• Catheter Gauge: 10 French
• Device Size Text, specify: 0
• Length: 105 Centimeter
• Catheter Gauge: 10 French
• Device Size Text, specify: 0
• Length: 105 Centimeter
• Catheter Gauge: 10 French
• Device Size Text, specify: 0
• Length: 105 Centimeter
• Catheter Gauge: 10 French
• Device Size Text, specify: 0
• Length: 105 Centimeter
• Catheter Gauge: 10 French
• Device Size Text, specify: 0

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dry, dark place.
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dry, dark place.
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dry, dark place.
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dry, dark place.
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dry, dark place.
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dry, dark place.
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dry, dark place.
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dry, dark place.
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dry, dark place.
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dry, dark place.
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dry, dark place.
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dry, dark place.
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dry, dark place.
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dry, dark place.
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dry, dark place.
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dry, dark place.
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dry, dark place.

Device Identifiers

Device Issuing Agency	Device ID
GS1	14960685201396 [Primary]

FDA Product Code

• OZT: Balloon Aortic Valvuloplasty

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: 2023-06-09
• Device Publish Date: 2023-06-01

On-Brand Devices [INOUE BALLOON A]

• 14960685201433: PTAV-26RP
• 14960685201426: PTAV-24RP
• 14960685201419: PTAV-22RP
• 14960685201402: PTAV-20RP
• 14960685201396: PTAV-18RP
• 14960685201389: PTAV-16RP
• 14960685201358: PTAV-18R
• 14960685201341: PTAV-16R
• 14960685201259: PTAV-26R
• 14960685201242: PTAV-24R
• 14960685201235: PTAV-22R
• 14960685201228: PTAV-20R