Angio-Seal™ C610134

GUDID 05415067002839

ST. JUDE MEDICAL CARDIOVASCULAR DIVISION

Femoral artery closure plug/patch, collagen

• Primary Device ID: 05415067002839
• NIH Device Record Key: c1a849a9-bfe0-4cb8-9395-8f14f5625d05
• Commercial Distribution Discontinuation: 2017-04-20
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: Angio-Seal™
• Version Model Number: Evolution™
• Catalog Number: C610134
• 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: 6 French
• Catheter Gauge: 6 French
• Catheter Gauge: 6 French
• Catheter Gauge: 6 French
• Catheter Gauge: 6 French
• Catheter Gauge: 6 French
• Catheter Gauge: 6 French
• Catheter Gauge: 6 French
• Catheter Gauge: 6 French
• Catheter Gauge: 6 French

Operating and Storage Conditions

• 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
• 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.

Device Identifiers

Device Issuing Agency	Device ID
GS1	05415067002839 [Primary]
GS1	15415067002836 [Package]; Contains: 25415067002833; Package: [2 Units]; Discontinued: 2017-04-20; Not in Commercial Distribution
GS1	25415067002833 [Package]; 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