Portex

GUDID 50351688517263

SMITHS MEDICAL ASD, INC.

Benchtop nebulizer, non-heated Benchtop nebulizer, non-heated Benchtop nebulizer, non-heated Benchtop nebulizer, non-heated Benchtop nebulizer, non-heated Benchtop nebulizer, non-heated

• Primary Device ID: 50351688517263
• NIH Device Record Key: b56e3100-16d8-4bdc-90ee-6ae577c408a4
• Commercial Distribution Discontinuation: 2018-10-29
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: Portex
• Version Model Number: 4307SM
• Company DUNS: 828611934
• Company Name: SMITHS MEDICAL ASD, 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: false
• Expiration Date: false
• 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	10351688517265 [Primary]
GS1	50351688517263 [Package]; Contains: 10351688517265; Package: CASE [50 Units]; Discontinued: 2018-10-29; Not in Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K901315

FDA Product Code

• CAF: NEBULIZER (DIRECT PATIENT INTERFACE)

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2022-06-10
• Device Publish Date: 2016-10-11

On-Brand Devices [Portex]

• 30351688075110: A3682
• 30351688075097: A3690
• 30351688073994: A3616-25
• 30351688073970: A3607-25
• 30351688073840: A3599-26
• 30351688073826: A3606-22
• 30351688073819: A3608-25
• 30351688073765: A3583-20
• 30351688073758: G1751
• 30351688073741: A3602
• 30351688073734: A3582-27
• 30351688073727: A3580-22
• 30351688073710: A3601-18
• 30351688073703: A3600-17
• 30351688073697: G1749
• 30351688073673: A3584
• 30351688073666: A3595-17
• 30351688073659: A3591
• 30351688073635: A3589-20
• 10351688073624: A3590-18
• 30351688073611: A3588-20
• 30351688073062: 4044EG-1
• 30351688073055: 4591EG-1
• 30351688073048: 4620EG-1
• 30351688073031: 4660EG-1
• 30351688073024: 4077EG-1
• 30351688072874: A3577-22
• 30351688072867: A3563-25
• 30351688072836: A3559-25
• 30351688072812: A3574-17
• 30351688072782: A3572-17
• 30351688072768: A3570-25
• 30351688072737: A3567-18
• 30351688072720: A3565-17
• 30351688072706: A3562-24
• 30351688072690: A3557-18
• 30351688072683: A3560
• 30351688072638: A3556-24
• 30351688072621: A3555-17
• 30351688072584: A3553
• 30351688072577: A3511
• 30351688072553: A3550
• 30351688072539: A3514-25
• 30351688072522: A3513-18
• 30351688072515: A3512-18/27
• 30351688072454: A3536-24
• 30351688072430: A3546-17
• 30351688072379: G1742
• 30351688072362: A3533-22
• 30351688072355: A3537