Symphony™ Clot Container SYMPHONYCC

GUDID 10850032079164

Symphony Clot Container

IMPERATIVE CARE, INC.

Thrombectomy suction catheter Thrombectomy suction catheter Thrombectomy suction catheter Thrombectomy suction catheter Thrombectomy suction catheter Thrombectomy suction catheter Thrombectomy suction catheter Thrombectomy suction catheter Thrombectomy suction catheter Thrombectomy suction catheter Thrombectomy suction catheter Thrombectomy suction catheter Thrombectomy suction catheter Thrombectomy suction catheter Thrombectomy suction catheter Thrombectomy suction catheter Thrombectomy suction catheter Thrombectomy suction catheter

• Primary Device ID: 10850032079164
• NIH Device Record Key: b5b175ea-0762-48d6-8775-3fb048335e02
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Symphony™ Clot Container
• Version Model Number: SYMPHONYCC
• Catalog Number: SYMPHONYCC
• Company DUNS: 080816678
• Company Name: IMPERATIVE CARE, 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: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 1-833-878-8422
• Email: customerservice@imperativecare.com
• Phone: 1-833-878-8422
• Email: customerservice@imperativecare.com
• Phone: 1-833-878-8422
• Email: customerservice@imperativecare.com
• Phone: 1-833-878-8422
• Email: customerservice@imperativecare.com
• Phone: 1-833-878-8422
• Email: customerservice@imperativecare.com
• Phone: 1-833-878-8422
• Email: customerservice@imperativecare.com
• Phone: 1-833-878-8422
• Email: customerservice@imperativecare.com
• Phone: 1-833-878-8422
• Email: customerservice@imperativecare.com
• Phone: 1-833-878-8422
• Email: customerservice@imperativecare.com
• Phone: 1-833-878-8422
• Email: customerservice@imperativecare.com
• Phone: 1-833-878-8422
• Email: customerservice@imperativecare.com
• Phone: 1-833-878-8422
• Email: customerservice@imperativecare.com
• Phone: 1-833-878-8422
• Email: customerservice@imperativecare.com
• Phone: 1-833-878-8422
• Email: customerservice@imperativecare.com
• Phone: 1-833-878-8422
• Email: customerservice@imperativecare.com
• Phone: 1-833-878-8422
• Email: customerservice@imperativecare.com
• Phone: 1-833-878-8422
• Email: customerservice@imperativecare.com
• Phone: 1-833-878-8422
• Email: customerservice@imperativecare.com

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dry place.
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dry place.
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dry place.
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dry place.
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dry place.
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dry place.
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dry place.
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dry place.
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dry place.
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dry place.
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dry place.
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dry place.
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dry place.
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dry place.
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dry place.
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dry place.
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dry place.
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dry place.

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850032079167 [Primary]
GS1	10850032079164 [Package]; Contains: 00850032079167; Package: [6 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K223216

FDA Product Code

• QEW: Peripheral Mechanical Thrombectomy With Aspiration

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-02-12
• Device Publish Date: 2024-02-02

Devices Manufactured by IMPERATIVE CARE, INC.

• 00850032079174 - Symphony™ Advance™ Long Dilator: 2024-03-12 24F Symphony™ Advance™ Long Dilator
• 10850032079164 - Symphony™ Clot Container: 2024-02-12Symphony Clot Container
• 10850032079164 - Symphony™ Clot Container: 2024-02-12 Symphony Clot Container
• 00812212030573 - ZOOM™ 88 Large Distal Platform™ Support: 2023-06-12 ZOOM™ 88 088 LDP Support, 100 cm
• 00812212030511 - ZOOM™ RDL Radial Access System, 95cm: 2022-10-06 ZOOM™ RDL, 95cm with dilator
• 00812212030528 - ZOOM™ RDL Radial Access System, 105cm: 2022-10-06 ZOOM™ RDL, 105cm with dilator
• 00812212030535 - ZOOM™ RDL Radial Access System, 110cm: 2022-10-06 ZOOM™ RDL, 110cm with dilator
• 00812212030566 - ZOOM™ RDL Radial Access System, 103cm: 2022-10-06 ZOOM™ RDL, 103cm with dilator
• 00812212030399 - TracStar™ Large Distal Platform: 2022-08-19 TracStar™ LDP, 95 cm