Smiths Medical

GUDID 10351688518231

SMITHS MEDICAL ASD, INC.

Tracheostomy tube, non-reinforced, non-customized, reusable

• Primary Device ID: 10351688518231
• NIH Device Record Key: f3493fb1-71a5-4810-aa68-d9a1826f545d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Smiths Medical
• Version Model Number: 358035
• Company DUNS: 118112924
• Company Name: SMITHS MEDICAL ASD, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Conditional
• 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: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	10351688518231 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K944178

FDA Product Code

• JOH: Tube tracheostomy and tube cuff

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2024-09-12
• Device Publish Date: 2015-07-29

On-Brand Devices [Smiths Medical]

• 10351688518248: 358040
• 10351688518231: 358035
• 10351688518224: 358030
• 10351688518217: 358025
• 10351688518200: 353055
• 10351688518194: 353050
• 10351688518187: 353045
• 10351688518170: 353040
• 10351688518163: 353035
• 10351688518156: 353030
• 10351688518149: 353025