VECTRA®, VASCULAR ACCESS GRAFT 10002-5050-001

GUDID 00813024011330

Thoratec Corporation

Arteriovenous shunt

• Primary Device ID: 00813024011330
• NIH Device Record Key: c4e447d3-8cdd-4b0a-b9d1-28e23e9c3d86
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: VECTRA®, VASCULAR ACCESS GRAFT
• Version Model Number: 10002-5050-001
• Catalog Number: 10002-5050-001
• Company DUNS: 070156955
• Company Name: Thoratec Corporation
• 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: true
• 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: +1(855)478-5833
• Email: customerservice@sjm.com
• Phone: +1(855)478-5833
• Email: customerservice@sjm.com
• Phone: +1(855)478-5833
• Email: customerservice@sjm.com
• Phone: +1(855)478-5833
• Email: customerservice@sjm.com
• Phone: +1(855)478-5833
• Email: customerservice@sjm.com
• Phone: +1(855)478-5833
• Email: customerservice@sjm.com
• Phone: +1(855)478-5833
• Email: customerservice@sjm.com
• Phone: +1(855)478-5833
• Email: customerservice@sjm.com
• Phone: +1(855)478-5833
• Email: customerservice@sjm.com
• Phone: +1(855)478-5833
• Email: customerservice@sjm.com
• Phone: +1(855)478-5833
• Email: customerservice@sjm.com
• Phone: +1(855)478-5833
• Email: customerservice@sjm.com
• Phone: +1(855)478-5833
• Email: customerservice@sjm.com

Operating and Storage Conditions

• Storage Environment Temperature: Between 20 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 20 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 20 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 20 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 20 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 20 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 20 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 20 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 20 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 20 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 20 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 20 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 20 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00813024011330 [Primary]

FDA Product Code

• DSQ: Ventricular (Assisst) Bypass
• DYF: Prosthesis, Vascular Graft, Of Less Then 6mm Diameter

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 6
• Public Version Date: 2019-03-19
• Device Publish Date: 2014-09-20

On-Brand Devices [VECTRA®, VASCULAR ACCESS GRAFT]

• 00813024011453: 10002-6050-001
• 00813024011446: 10002-6040-001
• 00813024011439: 10002-6020-003
• 00813024011422: 10002-6020-002
• 00813024011330: 10002-5050-001
• 00813024011323: 10002-5040-001
• 00813024011316: 10002-5020-003
• 00813024011309: 10002-5020-002