RED 68

GUDID 00815948023901

Reperfusion Catheter RED 68 Kit, 132cm, CE

PENUMBRA, INC.

Thrombectomy suction catheter

• Primary Device ID: 00815948023901
• NIH Device Record Key: 12bf0f26-8333-47fc-823f-4f52c96c6801
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: RED 68
• Version Model Number: RED68KIT-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	00815948023901 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K211411

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: 2021-07-22
• Device Publish Date: 2021-07-14

On-Brand Devices [RED 68]

• 00815948024120: Reperfusion Catheter RED 68 Kit, 132cm, CE
• 00815948024113: Reperfusion Catheter RED 68 Kit, 132cm
• 00815948024106: Reperfusion Catheter RED 68, 132cm
• 00815948024090: Reperfusion Catheter RED 68, 132cm, CE
• 00815948023901: Reperfusion Catheter RED 68 Kit, 132cm, CE
• 00815948023895: Reperfusion Catheter RED 68 Kit, 132cm
• 00815948023888: Reperfusion Catheter RED 68, 132cm, CE
• 00815948023871: Reperfusion Catheter RED 68, 132cm
• 00815948024137: Reperfusion Catheter RED 68 Kit, 132cm