Portex

GUDID 50351688600019

SMITHS MEDICAL

Inhalation therapy saline solution, hypertonic

• Primary Device ID: 50351688600019
• NIH Device Record Key: 8f38ce75-0081-4ee3-ac1d-cbb2a5d38317
• Commercial Distribution Discontinuation: 2019-11-20
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: Portex
• Version Model Number: R0059
• Company DUNS: 835634168
• Company Name: SMITHS MEDICAL
• Device Count: 100
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00351688600014 [Primary]
GS1	10351688600011 [Unit of Use]
GS1	50351688600019 [Package]; Contains: 00351688600014; Package: Case [10 Units]; Discontinued: 2019-11-20; Not in Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K820227

FDA Product Code

• CAF: NEBULIZER (DIRECT PATIENT INTERFACE)

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2019-11-22
• Device Publish Date: 2016-12-01

On-Brand Devices [Portex]

• 50351688600019: R0059
• 50351688600002: R0039
• 50351688600125: 1065
• 50351688600118: 0552
• 50351688600101: 0352