Passio Disposable Collection System

GUDID 00860099001308

Bearpac Medical, LLC

Pleural/peritoneal drainage catheterization kit

• Primary Device ID: 00860099001308
• NIH Device Record Key: 9d8c7893-5d23-4357-9d36-4cef2b7f528d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Passio Disposable Collection System
• Version Model Number: PAS-07
• Company DUNS: 081178202
• Company Name: Bearpac Medical, 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

Customer Support Contacts

• Phone: 1-833-232-7722
• Email: cs@bearpac.com
• Phone: 1-833-232-7722
• Email: cs@bearpac.com

Operating and Storage Conditions

• Storage Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity

Device Identifiers

Device Issuing Agency	Device ID
GS1	00860099001308 [Primary]
GS1	10860099001305 [Package]; Package: Case [10 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K201404

FDA Product Code

• DWM: Apparatus, Suction, Patient Care

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: 2023-09-04
• Device Publish Date: 2023-08-25

Devices Manufactured by Bearpac Medical, LLC

• 00086000903220 - Passio Redressing Kit: 2024-03-08
• 10860099001398 - Passio Valve Cap Kit: 2024-03-08
• 00860099001308 - Passio Disposable Collection System: 2023-09-04
• 00860099001308 - Passio Disposable Collection System: 2023-09-04
• 10860099001343 - Passio Catheter Valve Replacement Kit: 2023-09-04
• 00860099001322 - Passio Pump Drainage System: 2023-08-21 Starter Pac
• 00860099001353 - Passio Adapter Kit: 2023-08-21