Passy-Muir

Basic Information

• Brand Name: Passy-Muir
• Primary DI: 10859760005070
• Version / Model: PM-DB15
• Catalog Number: PM-DB15
• Company Name: PASSY-MUIR, INC.
• Labeler DUNS: 174508630
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 3
• Record Status: Published
• Publish Date: 2022-08-04
• Public Version: 1
• Public Version Date: 2022-08-12
• Public Version Status: New
• Public Device Record Key: ea377c7a-85e9-46db-9730-2f0a1a37d68c

Device Description

Passy Muir Low-Profile DB15 Adapter

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: Yes
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: Yes
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• 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
BZA	Connector, Airway (Extension)	Anesthesiology	868.5810	1

GMDN Terms

Code	Name	Definition	Implantable	Status
63623	Tracheostomy tube adaptor	A device intended to facilitate the connection of another device [e.g., hands-free speech valve, heat and moisture exchanger (HME)] to a tracheostomy tube on the tracheostoma skin side. It is typically made of synthetic polymer materials and in the form of a connecting ring of various mating diameters. This is a single-patient reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Unit of Use	00859760005073	GS1
Primary	10859760005070	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]