Portex

Basic Information

• Brand Name: Portex
• Primary DI: 10788942540903
• Version / Model: 55-4090
• Company Name: SMITHS MEDICAL ASD, INC.
• Labeler DUNS: 828611934
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-10-11
• Public Version: 2
• Public Version Date: 2018-03-29
• Public Version Status: Update
• Public Device Record Key: 0833b35a-8386-4591-8a7f-a823d35e3f88

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• 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: No
• 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
BYI	PERCUSSOR, POWERED-ELECTRIC	Anesthesiology	868.5665	2

GMDN Terms

Code	Name	Definition	Implantable	Status
61027	Manual chest percussor	A hand-held device designed to facilitate manual percussion (rapid tapping) to provide external vibrations to the chest wall of a patient (neonate to adult) to loosen excessive airway secretions [mucus or sputum (phlegm)] to promote airway clearance and improve bronchial drainage for patients with respiratory disease [e.g., cystic fibrosis (CF), neuromuscular disease, bronchitis, bronchiectasis, chronic obstructive pulmonary disease (COPD)]. It is typically made of soft plastic, in the shape of a cup with a short handle, and available in a range of sizes. This a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	50788942540901	GS1	CASE	40	In Commercial Distribution
Primary	10788942540903	GS1