Tian Medical

GUDID 00864915000308

Tx360™ Nasal Applicator

Tian Medical, LLC

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• Primary Device ID: 00864915000308
• NIH Device Record Key: da9d3ea5-8606-4008-9e3d-a07c6b95e7d5
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Tian Medical
• Version Model Number: Tx360
• Company DUNS: 070075971
• Company Name: Tian Medical, LLC
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• 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: 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	00864915000308 [Primary]
GS1	00864915000315 [Package]; Package: Inner Pack [10 Units]; In Commercial Distribution

FDA Product Code

• EPN: Pump, Nebulizer, Manual

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-05-26
• Device Publish Date: 2021-05-18

On-Brand Devices [Tian Medical]

• 00864915000308: Tx360™ Nasal Applicator
• 20864915000302: Tx360EUTM Nasal Applicator