Portex

Basic Information

• Brand Name: Portex
• Primary DI: 50351688600101
• Version / Model: 0352
• Company Name: SMITHS MEDICAL
• Labeler DUNS: 835634168
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 20
• Record Status: Published
• Publish Date: 2016-12-01
• Public Version: 3
• Public Version Date: 2019-11-22
• Public Version Status: Update
• Public Device Record Key: b10a4d15-be8e-4cce-beee-cbdeb74e8208
• Distribution End Date: 2019-11-20

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: Yes
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
BTT	HUMIDIFIER, RESPIRATORY GAS, (DIRECT PATIENT INTERFACE)	Anesthesiology	868.5450	2

GMDN Terms

Code	Name	Definition	Implantable	Status
44706	Inhalation therapy sterile water	A quantity of sterile water (H2O) intended to prevent the drying of airway passages associated with a dry environment or the inhalation of medical gases. It is typically used with various types of inhalation therapy devices (e.g., humidifiers, nebulizers, oxygen therapy delivery systems) to increase the humidity of respired air through the addition of vaporized/atomized water to room air or to the gas stream of a breathing circuit. The water contains no additional solutes, is typically available in a plastic container of various sizes, and may be provided with an adaptor for connecting to the inhalation therapy device. After application, it cannot be reused.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	50351688600101	GS1
Unit of Use	10351688600103	GS1