RED 72 RED72SDKIT

GUDID 00815948029996

RED 72 with Sonic, no CE

PENUMBRA, INC.

Thrombectomy suction catheter

• Primary Device ID: 00815948029996
• NIH Device Record Key: 06f623b6-544e-45c2-813d-54e8d46d53ef
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: RED 72
• Version Model Number: RED72SDKIT-B
• Catalog Number: RED72SDKIT
• 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: true
• 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: true
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00815948029996 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K242104

FDA Product Code

• NRY: Catheter, Thrombus Retriever

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: 2025-02-28
• Device Publish Date: 2025-02-20

On-Brand Devices [RED 72]

• 00815948023932: Reperfusion Catheter RED 72 KIT, 132cm
• 00815948023918: Reperfusion Catheter RED 72, 132cm
• 00815948029996: RED 72 with Sonic, no CE
• 00815948029989: Reperfusion Catheter RED 72 KIT, 132cm
• 00815948029972: Reperfusion Catheter RED 72, 132cm