Tyvaso

GUDID 00366302000231

United Therapeutics Corporation

Benchtop nebulizer, non-heated

• Primary Device ID: 00366302000231
• NIH Device Record Key: e7f1ede7-c784-4eb9-9a7f-efb950841315
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Tyvaso
• Version Model Number: TD-300/A
• Company DUNS: 965460025
• Company Name: United Therapeutics Corporation
• 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: true
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: false
• Expiration Date: false
• 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	00366302000231 [Primary]

FDA Product Code

• CAF: Nebulizer (direct patient interface)

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: 2023-02-13
• Device Publish Date: 2023-02-03

Devices Manufactured by United Therapeutics Corporation

• 00850017421202 - RemunityPRO: 2025-08-15 RemunityPRO Cassette Overpack contains 24x DKUT-10006-001 RemunityPRO Cassette Pack
• 00850017421219 - RemunityPRO: 2025-08-15 RemunityPRO Cassette Pack contains 10 RemunityPRO Cassettes
• 00850017421226 - RemunityPRO: 2025-08-15 RemunityPRO Cassette
• 00850017421233 - RemunityPRO: 2025-08-15 RemunityPRO Starter Kit contains 2 pumps, 2 remote interfaces, chargers, batteries, and Instructions for Use. Required to initi
• 00850017421240 - RemunityPRO: 2025-08-15 RemunityPRO Pump
• 00850017421264 - RemunityPRO: 2025-08-15 RemunityPRO Remote Interface
• 00850017421271 - RemunityPRO: 2025-08-15 RemunityPRO Pump / Remote Replacement Kit contains one RemunityPRO Pump and one RemunityPRO Remote Interface
• 00366302000231 - Tyvaso: 2023-02-13
• 00366302000231 - Tyvaso: 2023-02-13