Portex

GUDID 55019315106604

Smiths Medical Czech Republic a.s.

Tracheostomy kit, single-use Tracheostomy kit, single-use

• Primary Device ID: 55019315106604
• NIH Device Record Key: db5ab9f2-c22b-49b4-99f3-9d762bdf20ab
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Portex
• Version Model Number: 100/541/080CZ
• Company DUNS: 361330253
• Company Name: Smiths Medical Czech Republic a.s.
• 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: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	15019315106606 [Primary]
GS1	35019315106600 [Package]; Contains: 15019315106606; Package: Box [1 Units]; In Commercial Distribution
GS1	55019315106604 [Package]; Contains: 35019315106600; Package: Case [10 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K060945

FDA Product Code

• BTO: Tube, tracheostomy (w/wo connector)

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: 2018-10-16
• Device Publish Date: 2016-04-04

On-Brand Devices [Portex]

• 55019315106956: 100/544/000
• 35019315110522: 100/465/060CZ
• 35019315106952: 100/544/000
• 15019315110528: 100/465/060CZ
• 55019315107243: 100/899/090CZ
• 55019315107236: 100/899/080CZ
• 55019315107229: 100/899/070CZ
• 55019315107212: 100/897/090CZ
• 35019315107201: 100/897/080CZ
• 55019315107199: 100/897/070CZ
• 55019315107182: 100/890/090CZ
• 55019315107175: 100/890/080CZ
• 35019315107164: 100/890/070CZ
• 35019315107157: 100/597/090CZ
• 55019315107144: 100/597/080CZ
• 15019315106958: 100/544/000
• 35019315106907: 100/892/200CZ
• 35019315106891: 100/891/090CZ
• 55019315106888: 100/891/080CZ
• 55019315106871: 100/891/070CZ
• 35019315106761: 100/572/000CZ
• 35019315106754: 100/562/000CZ
• 35019315106662: 100/541/070CZ
• 35019315106617: 100/541/090CZ
• 55019315106604: 100/541/080CZ
• 55019315103016: 100/597/070CZ
• 55019315103009: 100/549/000CZ
• 35019315104880: 100/870/090CZ
• 35019315104873: 100/870/085CZ
• 35019315104866: 100/870/080CZ
• 35019315104859: 100/870/075CZ
• 55019315104846: 100/870/070CZ
• 35019315104835: 100/870/060CZ
• 35019315107287: 100/386/010CZ