Indigo

GUDID 00814548019765

Ind Engine Canister Assembly, CE

PENUMBRA, INC.

Surgical irrigation/aspiration pump, reusable Surgical irrigation/aspiration pump, reusable Surgical irrigation/aspiration pump, reusable Surgical irrigation/aspiration pump, reusable Surgical irrigation/aspiration pump, reusable Surgical irrigation/aspiration pump, reusable Surgical irrigation/aspiration pump, reusable Surgical irrigation/aspiration pump, reusable Surgical irrigation/aspiration pump, reusable Surgical irrigation/aspiration pump, reusable Surgical irrigation/aspiration pump, reusable Surgical irrigation/aspiration pump, reusable Surgical irrigation/aspiration pump, reusable Surgical irrigation/aspiration pump, reusable Surgical irrigation/aspiration pump, reusable Surgical irrigation/aspiration pump, reusable Surgical irrigation/aspiration pump, reusable

• Primary Device ID: 00814548019765
• NIH Device Record Key: b9072a3a-cf2d-41b7-89a6-f48e7f11ad6d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Indigo
• Version Model Number: IAPS3
• 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: true
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00814548019765 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K180105

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: 2021-03-01
• Device Publish Date: 2021-02-19

On-Brand Devices [Indigo]

• 00814548017624: CATD
• 00814548017600: SEPD
• 00815948020481: Indigo CATD Kit
• 00815948022423: Indigo CATD Kit
• 00815948022348: Aspiration Catheter D Kit
• 00815948022331: Aspiration Catheter D Kit, CE
• 00814548019765: Ind Engine Canister Assembly, CE
• 00815948024281: Indigo CATD Kit