Tyvaso

GUDID 00366302000231

United Therapeutics Corporation

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

• 00366302000231 - Tyvaso: 2023-02-13
• 00366302000231 - Tyvaso: 2023-02-13
• 00850017421042 - Remunity: 2021-02-19 DKPI-11038-001 (Training Kit) consists of a package containing the following: - Charger Assembly x1 - Dual USB Adapter x 1 - USB
• 00850017421097 - Remunity: 2021-02-19 DKPI-21128-001 SPECIALTY PHARMACY ACCESSORY KIT 00850017421097 is one package containing: - (120) Luer caps (packaged in pouche
• 00850017421035 - Remunity: 2020-12-21 STARTER KIT, PHARMACY FILL, UNIT One starter kit consists of: - (2) Pumps - (2) Remotes - (4) Batteries - (2) Chargers - (4) USB
• 00850017421073 - Remunity: 2020-12-21 OVER PACK, DISPOSABLE KIT, UNITY 00850017421073 package contains: 10 packs of 12ea. disposable reservoirs