RED

GUDID 00815948023536

RED 62 Kit, 138cm, Jon Snow Tubing

PENUMBRA, INC.

Thrombectomy suction catheter

• Primary Device ID: 00815948023536
• NIH Device Record Key: 37ae8b00-4c0d-4964-a1ac-f04a0275f694
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: RED
• Version Model Number: RED62SKIT-B
• 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	00815948023536 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K203440

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: 2021-06-01
• Device Publish Date: 2021-05-24

On-Brand Devices [RED]

• 00815948023536: RED 62 Kit, 138cm, Jon Snow Tubing
• 00815948023475: RED 62, 138cm