Benchmark MAX System

GUDID 00815948022645

BMX96 90cm, 6F BER 125cm Select

PENUMBRA, INC.

Vascular microcatheter

• Primary Device ID: 00815948022645
• NIH Device Record Key: b02ee2e2-585c-483c-910a-bec8106c4432
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Benchmark MAX System
• Version Model Number: BMX9690BER125-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	00815948022645 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K201271

FDA Product Code

• DQY: CATHETER, PERCUTANEOUS

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: 2020-09-07
• Device Publish Date: 2020-08-28

On-Brand Devices [Benchmark MAX System]

• 00815948023086: BMX96 100cm, MP Tip, 6F SIMV 125cm Select
• 00815948023079: BMX96 100cm, STR Tip, 6F SIMV 125cm Select
• 00815948023062: BMX96 100cm, MP Tip, 6F BER 125cm Select
• 00815948023055: BMX96 100cm, MP Tip, 6F H1 125cm Select
• 00815948023048: BMX96 100cm, STR Tip, 6F H1 125cm Select
• 00815948023031: BMX96 100cm, MP Tip, 6F SIM 125cm Select
• 00815948022713: BMX96 100cm, 6F SIM 125cm Select
• 00815948022706: BMX96 100cm, 6F BER 125cm Select
• 00815948022690: BMX96 90cm, MP Tip, 6F SIMV 125cm Select
• 00815948022683: BMX96 90cm, MP Tip, 6F SIM 125cm Select
• 00815948022676: BMX96 90cm, MP Tip, 6F BER 125cm Select
• 00815948022669: BMX96 90cm, 6F SIMV 125cm Select
• 00815948022652: BMX96 90cm, 6F SIM 125cm Select
• 00815948022645: BMX96 90cm, 6F BER 125cm Select
• 00815948022638: BMX96 80cm, 6F BER 105cm Select
• 00815948022621: BMX96 100cm
• 00815948022614: BMX96 90cm
• 00815948022607: BMX96 80cm
• 00815948024670: BMX81 95cm, MP Tip
• 00815948024663: BMX81 95cm
• 00815948024656: BMX81 95cm, MP Tip, 5F BER 120cm Select
• 00815948024649: BMX81 95cm, 5F BER 120cm Select
• 00815948024632: BMX81 95cm, MP Tip, 5F SIM 120cm Select
• 00815948024625: BMX81 95cm, 5F SIM 120cm Select
• 00815948024618: BMX81 105cm, MP Tip
• 00815948024601: BMX81 105cm
• 00815948024595: BMX81 105cm, MP Tip, 5F BER 130cm Select
• 00815948024588: BMX81 105cm, 5F BER 130cm Select
• 00815948024571: BMX81 105cm, MP Tip, 5F SIM 130cm Select
• 00815948024564: BMX81 105cm, 5F SIM 130cm Select
• 00815948024557: BMX81 115cm, MP Tip
• 00815948024540: BMX81 115cm
• 00815948024533: BMX81 115cm, MP Tip, 5F BER 130cm Select
• 00815948024526: BMX81 115cm, 5F BER 130cm Select
• 00815948024519: BMX81 115cm, MP Tip, 5F SIM 130cm Select
• 00815948024502: BMX81 115cm, 5F SIM 130cm Select
• 00815948026384: BMX96 80cm, STR Tip
• 00815948026377: BMX96 80cm, STR Tip, 6F BER 105cm Select
• 00815948026360: BMX96 90cm, STR Tip
• 00815948026353: BMX96 90cm, MP Tip, 6F SIMV 125cm Select
• 00815948026346: BMX96 90cm, STR Tip, 6F SIMV 125cm Select
• 00815948026339: BMX96 90cm, MP Tip, 6F BER 125cm Select
• 00815948026322: BMX96 90cm, STR Tip, 6F BER 125cm Select
• 00815948026315: BMX96 90cm, MP Tip, 6F SIM 125cm Select
• 00815948026308: BMX96 90cm, STR Tip, 6F SIM 125cm Select
• 00815948026292: BMX96 100cm, STR Tip
• 00815948026285: BMX96 100cm, MP Tip, 6F SIMV 125cm Select
• 00815948026278: BMX96 100cm, STR Tip, 6F SIMV 125cm Select
• 00815948026261: BMX96 100cm, MP Tip, 6F BER 125cm Select
• 00815948026254: BMX96 100cm, STR Tip, 6F BER 125cm Select