Alembic Aspiration Tubing

GUDID 00850014025007

Alembic, LLC

Suction/irrigation tubing, single-use

• Primary Device ID: 00850014025007
• NIH Device Record Key: 7627f2b3-536f-4106-8503-210af7e27d44
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Alembic Aspiration Tubing
• Version Model Number: FG-01001
• 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

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	00850014025007 [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

Devices Manufactured by Alembic, LLC

• 00850014025069 - APRO 70 Catheter: 2024-07-30
• 00850014025052 - APRO 55 Catheter: 2024-04-16
• 00850014025083 - APRO 55 Intermediate Catheter: 2024-04-16
• 00850014025090 - APRO 55 Intermediate Catheter: 2024-04-16
• 00850014025250 - APRO 55 Catheter: 2024-04-16
• 00850014025007 - Alembic Aspiration Tubing: 2023-05-05
• 00850014025007 - Alembic Aspiration Tubing: 2023-05-05
• 00850014025014 - APRO 70 Catheter: 2023-05-05
• 00850014025021 - APRO 70 Catheter: 2023-05-05