Penumbra System

GUDID 00814548019918

5MAXJET7KIT-A

PENUMBRA, INC.

Thrombectomy suction catheter

• Primary Device ID: 00814548019918
• NIH Device Record Key: abc4842f-c0e4-4a35-b62d-e00e3aae5e45
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Penumbra System
• Version Model Number: 5MAXJET7KIT-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	00814548019918 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K173761

FDA Product Code

• NRY: Catheter, Thrombus Retriever

Sterilization

• Steralize Prior To Use: true
• Device Is Sterile: true

[00814548019918]

Ethylene Oxide

[00814548019918]

Ethylene Oxide

[00814548019918]

Ethylene Oxide

[00814548019918]

Ethylene Oxide

[00814548019918]

Ethylene Oxide

[00814548019918]

Ethylene Oxide

[00814548019918]

Ethylene Oxide

[00814548019918]

Ethylene Oxide

[00814548019918]

Ethylene Oxide

[00814548019918]

Ethylene Oxide

[00814548019918]

Ethylene Oxide

[00814548019918]

Ethylene Oxide

[00814548019918]

Ethylene Oxide

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-02-04
• Device Publish Date: 2019-01-03

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• 00814548019901: 5MAXJET7-A
• 00814548019895: 5MAXJET7L127-A
• 00814548019888: 5MAXJET7L125-A
• 00814548019871: 5MAXJET7L120-A
• 00814548019864: 5MAXJET7L115-A
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• 00814548017853: PSR3D-A
• 00814548017839: 3d Revascularization Device
• 00814548017532: 5MAXACE068KIT-B
• 00814548017525: 5MAXACE068-B
• 00814548017518: 5MAXACE068L127-B
• 00814548017501: 5MAXACE068L120-B
• 00814548017495: 5MAXACE068L125-B
• 00814548017488: 5MAXACE068L115-B
• 00814548017433: 5MAXACE132KIT-A
• 00814548017426: 5MAXACE132-A
• 00814548017419: 5MAXACE127-A
• 00814548017402: 5MAXACE125-A
• 00814548016771: PSC054KIT
• 00814548016757: 3MAXCKIT
• 00814548016740: 4MAXCKIT
• 00814548016597: 5MAXACE068KIT-A
• 00814548016580: 5MAXACE068-A
• 00814548016573: 5MAXACE068L127-A
• 00814548016566: 5MAXACE068L125-A
• 00814548016559: 5MAXACE068L120-A
• 00814548016542: 5MAXACE068L115-A
• 00814548016481: 5MAXACE064KIT-A
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• 00814548016184: RC ACE 64, 125cm, noCE
• 00814548016177: RC ACE 64, 120cm, noCE
• 00814548016160: RC ACE 64, 115cm, noCE
• 00814548016139: SmtCoil Handle
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• 00814548013275: 4MAX DDC, 130cm
• 00814548012803: RC5MAX ACE, 132cm
• 00814548012797: RC5MAX ACE, 127cm
• 00814548012780: RC5MAX ACE, 125cm
• 00814548012773: Pump Max 110V
• 00814548012766: PS MAX RC5MAX 127cm, CE
• 00814548012759: PS MAX RC5MAX 125cm
• 00814548012742: PS Max RC5MAX 132cm, CE
• 00814548012698: Pump Max 220V
• 00814548012674: 5MAX DDC, 125cm