APRO 70 Catheter

GUDID 00850014025014

Alembic, LLC

Thrombectomy suction catheter

• Primary Device ID: 00850014025014
• NIH Device Record Key: bf97e2bb-5ac1-4ece-b61e-9115e4c2f7a1
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: APRO 70 Catheter
• Version Model Number: APRO-70-135
• 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

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Store in a dry place
• Special Storage Condition, Specify: Between 0 and 0 *Store in a dry place
• Special Storage Condition, Specify: Between 0 and 0 *Store in a dry place
• Special Storage Condition, Specify: Between 0 and 0 *Store in a dry place
• Special Storage Condition, Specify: Between 0 and 0 *Store in a dry place
• Special Storage Condition, Specify: Between 0 and 0 *Store in a dry place
• Special Storage Condition, Specify: Between 0 and 0 *Store in a dry place
• Special Storage Condition, Specify: Between 0 and 0 *Store in a dry place
• Special Storage Condition, Specify: Between 0 and 0 *Store in a dry place
• Special Storage Condition, Specify: Between 0 and 0 *Store in a dry place
• Special Storage Condition, Specify: Between 0 and 0 *Store in a dry place
• Special Storage Condition, Specify: Between 0 and 0 *Store in a dry place
• Special Storage Condition, Specify: Between 0 and 0 *Store in a dry place
• Special Storage Condition, Specify: Between 0 and 0 *Store in a dry place
• Special Storage Condition, Specify: Between 0 and 0 *Store in a dry place
• Special Storage Condition, Specify: Between 0 and 0 *Store in a dry place
• Special Storage Condition, Specify: Between 0 and 0 *Store in a dry place

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850014025014 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K223545

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