Passio Handheld Control Unit

Basic Information

• Brand Name: Passio Handheld Control Unit
• Primary DI: 00860099001315
• Version / Model: PAS-03
• Company Name: Bearpac Medical, LLC
• Labeler DUNS: 081178202
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2025-07-07
• Public Version: 1
• Public Version Date: 2025-07-15
• Public Version Status: New
• Public Device Record Key: 6d181d96-eb02-467c-8e88-28b79785c569

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: Yes
• Has Serial Number: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: Yes
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
DWM	Apparatus, Suction, Patient Care	Cardiovascular	870.5050	2

GMDN Terms

Code	Name	Definition	Implantable	Status
63645	Thoracic suction pump	An electrically-powered, portable device, which may include noninvasive accessories, intended to generate negative pressure specifically for aspiration of the pleural cavity and/or mediastinum. It is a dedicated device intended to remove fluids (e.g., blood), secretions, and air to allow for the normal expansion/function of the lungs and/or mediastinum. The device may incorporate a display and may include collection containers or tubing; it does not include patient contact devices (e.g., catheter).	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00860099001315	GS1