Angio-Seal™ 610131

GUDID 25415067002857

ST. JUDE MEDICAL CARDIOVASCULAR DIVISION

Femoral artery closure plug/patch, collagen Femoral artery closure plug/patch, collagen Femoral artery closure plug/patch, collagen Femoral artery closure plug/patch, collagen Femoral artery closure plug/patch, collagen Femoral artery closure plug/patch, collagen Femoral artery closure plug/patch, collagen Femoral artery closure plug/patch, collagen Femoral artery closure plug/patch, collagen Femoral artery closure plug/patch, collagen

• Primary Device ID: 25415067002857
• NIH Device Record Key: f1e19321-14a9-4992-ab47-298f3abaa46d
• Commercial Distribution Discontinuation: 2017-04-20
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: Angio-Seal™
• Version Model Number: VIP
• Catalog Number: 610131
• Company DUNS: 040960379
• Company Name: ST. JUDE MEDICAL CARDIOVASCULAR DIVISION
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Safe
• 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

Device Dimensions

• Catheter Gauge: 8 French
• Catheter Gauge: 8 French
• Catheter Gauge: 8 French
• Catheter Gauge: 8 French
• Catheter Gauge: 8 French
• Catheter Gauge: 8 French
• Catheter Gauge: 8 French
• Catheter Gauge: 8 French
• Catheter Gauge: 8 French
• Catheter Gauge: 8 French

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Keep dry and Keep away from sunlight. Do not use if temperature indicator dot has changed from light gray to dark gray or black.
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry and Keep away from sunlight. Do not use if temperature indicator dot has changed from light gray to dark gray or black.
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry and Keep away from sunlight. Do not use if temperature indicator dot has changed from light gray to dark gray or black.
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry and Keep away from sunlight. Do not use if temperature indicator dot has changed from light gray to dark gray or black.
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry and Keep away from sunlight. Do not use if temperature indicator dot has changed from light gray to dark gray or black.
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry and Keep away from sunlight. Do not use if temperature indicator dot has changed from light gray to dark gray or black.
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry and Keep away from sunlight. Do not use if temperature indicator dot has changed from light gray to dark gray or black.
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry and Keep away from sunlight. Do not use if temperature indicator dot has changed from light gray to dark gray or black.
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry and Keep away from sunlight. Do not use if temperature indicator dot has changed from light gray to dark gray or black.
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry and Keep away from sunlight. Do not use if temperature indicator dot has changed from light gray to dark gray or black.
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	05415067002853 [Primary]
GS1	15415067002850 [Package]; Package: [2 Units]; Discontinued: 2017-04-20; Not in Commercial Distribution
GS1	25415067002857 [Package]; Contains: 05415067002853; Package: [5 Units]; Discontinued: 2017-04-20; Not in Commercial Distribution

FDA Product Code

• MGB: DEVICE, HEMOSTASIS, VASCULAR

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2018-10-22
• Device Publish Date: 2014-10-24

On-Brand Devices [Angio-Seal™]

• 05415067002877: STS Plus
• 05415067002860: STS Plus
• 25415067002857: VIP
• 05415067002846: Evolution™
• 05415067002839: Evolution™
• 05414734054591: VIP