Portex

Basic Information

• Brand Name: Portex
• Primary DI: 15019315022296
• Version / Model: 100/199/055
• Company Name: Smiths Medical International Ltd
• Labeler DUNS: 215591523
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2015-09-01
• Public Version: 2
• Public Version Date: 2018-03-29
• Public Version Status: Update
• Public Device Record Key: dae6573a-9cf6-4aa4-9f28-89336dce88f7

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
BTR	Tube, tracheal (w/wo connector)	Anesthesiology	868.5730	2

GMDN Terms

Code	Name	Definition	Implantable	Status
46968	Suprapubic cannula/trocar, reusable	A tubular device designed for percutaneous insertion into the bladder or renal pelvis through the suprapubic region. It typically consists of a metallic tube or a semi-rigid or rigid plastic tube that includes a trocar in its lumen to assist in the insertion and provide rigidity. The trocar is withdrawn after insertion leaving a hollow channel that is used for the drainage of urine, and/or for the insertion of a catheter or other appropriate device. This is a reusable device.	No	Obsolete

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	55019315022294	GS1	CASE	6	In Commercial Distribution
Package	35019315022290	GS1	BOX	20	In Commercial Distribution
Primary	15019315022296	GS1