Symphony™ 16F 82cm Catheter SYMPHONY16F82

GUDID 00850032079211

16F 82cm Symphony™ Catheter w/ Dilator

IMPERATIVE CARE, INC.

Thrombectomy suction catheter

• Primary Device ID: 00850032079211
• NIH Device Record Key: a2f35eb4-0f2a-480a-b6fa-d47fad67649e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Symphony™ 16F 82cm Catheter
• Version Model Number: SYMPHONY16F 82
• Catalog Number: SYMPHONY16F82
• 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

Device Dimensions

• Introducer Sheath Compatibilit: 16 French
• Catheter Working Length: 82 Centimeter
• Introducer Sheath Compatibilit: 16 French
• Catheter Working Length: 82 Centimeter
• Introducer Sheath Compatibilit: 16 French
• Catheter Working Length: 82 Centimeter
• Introducer Sheath Compatibilit: 16 French
• Catheter Working Length: 82 Centimeter
• Introducer Sheath Compatibilit: 16 French
• Catheter Working Length: 82 Centimeter
• Introducer Sheath Compatibilit: 16 French
• Catheter Working Length: 82 Centimeter
• Introducer Sheath Compatibilit: 16 French
• Catheter Working Length: 82 Centimeter
• Introducer Sheath Compatibilit: 16 French
• Catheter Working Length: 82 Centimeter
• Introducer Sheath Compatibilit: 16 French
• Catheter Working Length: 82 Centimeter
• Introducer Sheath Compatibilit: 16 French
• Catheter Working Length: 82 Centimeter
• Introducer Sheath Compatibilit: 16 French
• Catheter Working Length: 82 Centimeter
• Introducer Sheath Compatibilit: 16 French
• Catheter Working Length: 82 Centimeter
• Introducer Sheath Compatibilit: 16 French
• Catheter Working Length: 82 Centimeter
• Introducer Sheath Compatibilit: 16 French
• Catheter Working Length: 82 Centimeter
• Introducer Sheath Compatibilit: 16 French
• Catheter Working Length: 82 Centimeter

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850032079211 [Primary]

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: 2024-08-19
• Device Publish Date: 2024-08-09

Devices Manufactured by IMPERATIVE CARE, INC.

• 00850032079211 - Symphony™ 16F 82cm Catheter: 2024-08-1916F 82cm Symphony™ Catheter w/ Dilator
• 00850032079211 - Symphony™ 16F 82cm Catheter: 2024-08-19 16F 82cm Symphony™ Catheter w/ Dilator
• 00812212030603 - Zoom™ 6F Insert Catheter, VTK: 2024-06-26 Zoom™ 6F Insert Catheter, VTK, 140cm
• 00812212030627 - Zoom™ 6F Insert Catheter, VRT: 2024-06-26 Zoom™ 6F Insert Catheter, VRT, 137cm
• 00812212030696 - Zoom™ 6F Insert Catheter, SIM: 2024-06-26 Zoom™ 6F Insert Catheter, SIM, 143cm
• 00850032079174 - Symphony™ Advance™ Long Dilator: 2024-03-12 24F Symphony™ Advance™ Long Dilator
• 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