APRO 55 Catheter

GUDID 00850014025250

Alembic, LLC

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• Primary Device ID: 00850014025250
• NIH Device Record Key: 3c025e6f-f1c4-49a2-887e-2fb9e0fe761e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: APRO 55 Catheter
• Version Model Number: APRO-55-125
• Company DUNS: 065914268
• Company Name: Alembic, LLC
• 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: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850014025250 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K232971

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: 2024-04-16
• Device Publish Date: 2024-04-08

On-Brand Devices [APRO 55 Catheter]

• 00850014025250: APRO-55-125
• 00850014025052: APRO-55-137