Indigo Aspiration System

GUDID 00814548019703

IS ENGINE Canister Assembly

PENUMBRA, INC.

Surgical irrigation/aspiration system Surgical irrigation/aspiration system

• Primary Device ID: 00814548019703
• NIH Device Record Key: a7b5c151-4b0d-4916-b76c-8b8c2d109845
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Indigo Aspiration System
• Version Model Number: IAPS3-A
• Company DUNS: 191077671
• Company Name: PENUMBRA, 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: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00814548019703 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K180105

FDA Product Code

• DXE: Catheter, Embolectomy

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2018-11-08
• Device Publish Date: 2018-10-08

Devices Manufactured by PENUMBRA, INC.

• 00815948024779 - Swift Coil System: 2024-04-24 SwiftPAC Coil, 3 cm
• 00815948024793 - Swift Coil System: 2024-04-24 SwiftPAC Coil, 4 cm
• 00815948029460 - REAL y-Series: 2024-04-24 REAL y-Series 2
• 00815948029477 - REAL y-Series: 2024-04-24 REAL y-Series 2 Eval
• 00815948029484 - REAL y-Series: 2024-04-24 REAL y-Series GO
• 00815948029507 - Swift Coil System: 2024-04-24 SwiftPAC Coil, 5 cm
• 00815948029514 - Swift Coil System: 2024-04-24 SwiftPAC Coil, 6 cm
• 00815948029521 - Swift Coil System: 2024-04-24 SwiftPAC Coil, 7 cm