APRO 70 Catheter

GUDID 00850014025021

Alembic, LLC

Vascular guide-catheter, single-use

• Primary Device ID: 00850014025021
• NIH Device Record Key: 95048fc7-1ded-4730-a7ee-483013c46721
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: APRO 70 Catheter
• Version Model Number: APRO-70-125
• 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: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850014025021 [Primary]

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: 2023-05-05
• Device Publish Date: 2023-04-27

On-Brand Devices [APRO 70 Catheter]

• 00850014025038: APRO-70-132
• 00850014025021: APRO-70-125
• 00850014025014: APRO-70-135
• 00850014025069: FG-01016-N32