V8 V8-1924

GUDID 00859945004112

V8 Balloon Aortic Valvuloplasty Catheter, V8-1924

INTERVALVE INC

Cardiac valvuloplasty catheter

• Primary Device ID: 00859945004112
• NIH Device Record Key: 2e265b6c-e000-43f5-a325-1d510db2f779
• Commercial Distribution Discontinuation: 2018-09-08
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: V8
• Version Model Number: V8-1924
• Catalog Number: V8-1924
• Company DUNS: 037375827
• Company Name: INTERVALVE 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: true
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 6123969849
• Email: spetrie@libramed.com

Device Dimensions

• Device Size Text, specify: 0

Operating and Storage Conditions

• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00859945004112 [Primary]

FDA Product Code

• OZT: Balloon Aortic 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: 3
• Public Version Date: 2018-09-10
• Device Publish Date: 2016-09-08

On-Brand Devices [V8]

• 00859945004174: V8 Balloon Aortic Valvuloplasty Catheter, TAV8-2328
• 00859945004167: V8 Balloon Aortic Valvuloplasty Catheter, TAV8-2126
• 00859945004150: V8 Balloon Aortic Valvuloplasty Catheter, TAV8-1924
• 00859945004143: V8 Balloon Aortic Valvuloplasty Catheter, TAV8-1722
• 00859945004136: V8 Balloon Aortic Valvuloplasty Catheter, V8-2328
• 00859945004129: V8 Balloon Aortic Valvuloplasty Catheter, V8-2126
• 00859945004112: V8 Balloon Aortic Valvuloplasty Catheter, V8-1924
• 00859945004105: V8 Balloon Aortic Valvuloplasty Catheter, V8-1722
• 00859945004099: V8 Balloon Aortic Valvuloplasty Catheter, 232812C110
• 00859945004082: V8 Balloon Aortic Valvuloplasty Catheter, 212612C110
• 00859945004075: V8 Balloon Aortic Valvuloplasty Catheter, 192412C110
• 00859945004068: V8 Balloon Aortic Valvuloplasty Catheter, 172212C110