Portex

Basic Information

• Brand Name: Portex
• Primary DI: 20351688074574
• Version / Model: W1138
• Company Name: SMITHS MEDICAL ASD, INC.
• Labeler DUNS: 137835299
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2015-10-21
• Public Version: 3
• Public Version Date: 2020-10-21
• Public Version Status: Update
• Public Device Record Key: 78c80481-7c1f-49b8-ba9f-b5b97543ac61
• Distribution End Date: 2015-10-23

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: Yes
• 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: 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
BTO	Tube, tracheostomy (w/wo connector)	Anesthesiology	868.5800	2

GMDN Terms

Code	Name	Definition	Implantable	Status
14090	Tracheostomy care kit, single-use	A collection of sterile devices and supplies intended to be used for the maintenance of a tracheostomy (i.e., removal and cleaning of tracheostomy tube prior to reinsertion). It typically includes towels, gauze, swabs, cleaning brush, and gloves. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	30351688074571	GS1	CARTON	20	Not in Commercial Distribution	2015-07-31
Primary	20351688074574	GS1