RED 43

GUDID 00815948028166

Reperfusion Catheter RED 43 Kit, 153cm, Jon Snow Tubing, no CE

PENUMBRA, INC.

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• Primary Device ID: 00815948028166
• NIH Device Record Key: 33725e49-5cd2-49bb-b7d1-0d8470eb8617
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: RED 43
• Version Model Number: RED43KIT153-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: 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	00815948028166 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K222808

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: 2024-04-10
• Device Publish Date: 2024-04-02

On-Brand Devices [RED 43]

• 00815948028173: Reperfusion Catheter RED 43 Kit, 153cm, 110 Tubing, no CE
• 00815948028166: Reperfusion Catheter RED 43 Kit, 153cm, Jon Snow Tubing, no CE
• 00815948028159: Reperfusion Catheter RED 43, 153cm, no CE