ANGIO-SEAL C610135

GUDID 50389701011771

ANGIO-SEAL EVOLUTION Vascular Closure Device

TERUMO MEDICAL CORPORATION

Femoral artery closure plug/patch, collagen

• Primary Device ID: 50389701011771
• NIH Device Record Key: 103d6868-f623-4f4a-aad3-57add656a07f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ANGIO-SEAL
• Version Model Number: C610135
• Catalog Number: C610135
• Company DUNS: 962520628
• Company Name: TERUMO MEDICAL CORPORATION
• 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: true
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(800)283-7866
• Email: tmccustomer.admin@terumomedical.com
• Phone: +1(800)283-7866
• Email: tmccustomer.admin@terumomedical.com
• Phone: +1(800)283-7866
• Email: tmccustomer.admin@terumomedical.com
• Phone: +1(800)283-7866
• Email: tmccustomer.admin@terumomedical.com
• Phone: +1(800)283-7866
• Email: tmccustomer.admin@terumomedical.com
• Phone: +1(800)283-7866
• Email: tmccustomer.admin@terumomedical.com
• Phone: +1(800)283-7866
• Email: tmccustomer.admin@terumomedical.com
• Phone: +1(800)283-7866
• Email: tmccustomer.admin@terumomedical.com
• Phone: +1(800)283-7866
• Email: tmccustomer.admin@terumomedical.com
• Phone: +1(800)283-7866
• Email: tmccustomer.admin@terumomedical.com
• Phone: +1(800)283-7866
• Email: tmccustomer.admin@terumomedical.com
• Phone: +1(800)283-7866
• Email: tmccustomer.admin@terumomedical.com
• Phone: +1(800)283-7866
• Email: tmccustomer.admin@terumomedical.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
• 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, including UV light. Do not use if temperature indicator dot has changed from light gray to dark gray or black.
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry and Keep away from sunlight, including UV light. 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, including UV light. 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, including UV light. 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, including UV light. 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, including UV light. 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, including UV light. 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, including UV light. 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, including UV light. 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, including UV light. 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, including UV light. 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, including UV light. 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, including UV light. 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, including UV light. 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	00389701011776 [Primary]
GS1	30389701011777 [Package]; Contains: 00389701011776; Package: Shelfbox [5 Units]; In Commercial Distribution
GS1	50389701011771 [Package]; Contains: 30389701011777; Package: Carton [2 Units]; 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: 2017-04-20

On-Brand Devices [ANGIO-SEAL]

• 30389701011869: ANGIO-SEAL STS Plus Vascular Closure Device
• 50389701011856: ANGIO-SEAL STS Plus Vascular Closure Device
• 50389701011825: ANGIO-SEAL VIP Vascular Closure Device
• 50389701011818: ANGIO-SEAL VIP Vascular Closure Device
• 30389701011784: ANGIO-SEAL EVOLUTION Vascular Closure Device
• 50389701011771: ANGIO-SEAL EVOLUTION Vascular Closure Device