Portex

GUDID 30351688428350

SMITHS MEDICAL MD, INC.

Airway pressure monitor, non-powered

• Primary Device ID: 30351688428350
• NIH Device Record Key: 054134b9-a805-4094-9ca6-4293bb8d885c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Portex
• Version Model Number: 008201
• Company DUNS: 106712748
• Company Name: SMITHS MEDICAL MD, INC.
• Device Count: 1
• 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: true
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	10351688426352 [Primary]
GS1	30351688428350 [Package]; Contains: 10351688426352; Package: Case [20 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K961318

FDA Product Code

• CAP: MONITOR, AIRWAY PRESSURE (INCLUDES GAUGE AND/OR ALARM)

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-03-03
• Device Publish Date: 2021-02-23

On-Brand Devices [Portex]

• 55019517046227: 101/506/050
• 35019517046216: 101/506/045
• 35019517046209: 101/506/040
• 35019517046193: 101/506/035
• 35019517046186: 101/506/030
• 35019517086274: 24-2233-01
• 35019517086267: 24-2232-01
• 35019517086250: 24-2231-01
• 35019517086243: 24-2230-01
• 35019517086236: 24-2229-01
• 35019517086229: 24-2228-01
• 35019517086205: 24-2227-01
• 35019517086182: 24-2226-01
• 35019517086175: 24-2225-01
• 35019517086151: 24-2224-01
• 35019517086120: 24-2223-01
• 35019517085888: 24-2220-01
• 35019517085857: 24-2219-01
• 35019517085840: 24-2218-01
• 35019517085833: 24-2217-01
• 35019517085826: 24-2216-01
• 35019517085819: 24-2215-01
• 35019517085802: 24-2214-01
• 35019517085710: 24-2213-01
• 35019517085680: 24-2212-01
• 35019517085666: 24-2211-01
• 35019517085451: 24-2210-01
• 15019517074789: 24-2221-01
• 30351688428350: 008201
• 10788942270152: 21-7015