Tyvaso

GUDID 00366302000231

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 Issuing Agency	Device ID
GS1	00366302000231 [Primary]

CAF	Nebulizer (direct patient interface)

Steralize Prior To Use	false
Device Is Sterile	false

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

Mark Image Registration \| Serial	Company Trademark Application Date
TYVASO 77425786 3709561 Live/Registered	UNITED THERAPEUTICS CORPORATION 2008-03-19