Ultravent N684A0

GUDID 00369945000019

Ultravent Radioaerosol Delivery System

CURIUM US LLC

Nebulizing system delivery set, single-use Nebulizing system delivery set, single-use Nebulizing system delivery set, single-use Nebulizing system delivery set, single-use Nebulizing system delivery set, single-use Nebulizing system delivery set, single-use Nebulizing system delivery set, single-use Nebulizing system delivery set, single-use Nebulizing system delivery set, single-use Nebulizing system delivery set, single-use Nebulizing system delivery set, single-use Nebulizing system delivery set, single-use Nebulizing system delivery set, single-use Nebulizing system delivery set, single-use Nebulizing system delivery set, single-use Nebulizing system delivery set, single-use Nebulizing system delivery set, single-use Nebulizing system delivery set, single-use

• Primary Device ID: 00369945000019
• NIH Device Record Key: f694921e-9397-4bdb-b2ee-8ad2d5a307f4
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Ultravent
• Version Model Number: 1
• Catalog Number: N684A0
• Company DUNS: 079875617
• Company Name: CURIUM US LLC
• 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: true
• 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

Customer Support Contacts

• Phone: +1(866)789-2211
• Email: pvnorthamerica@curiumpharma.com
• Phone: +1(866)789-2211
• Email: pvnorthamerica@curiumpharma.com
• Phone: +1(866)789-2211
• Email: pvnorthamerica@curiumpharma.com
• Phone: +1(866)789-2211
• Email: pvnorthamerica@curiumpharma.com
• Phone: +1(866)789-2211
• Email: pvnorthamerica@curiumpharma.com
• Phone: +1(866)789-2211
• Email: pvnorthamerica@curiumpharma.com
• Phone: +1(866)789-2211
• Email: pvnorthamerica@curiumpharma.com
• Phone: +1(866)789-2211
• Email: pvnorthamerica@curiumpharma.com
• Phone: +1(866)789-2211
• Email: pvnorthamerica@curiumpharma.com
• Phone: +1(866)789-2211
• Email: pvnorthamerica@curiumpharma.com
• Phone: +1(866)789-2211
• Email: pvnorthamerica@curiumpharma.com
• Phone: +1(866)789-2211
• Email: pvnorthamerica@curiumpharma.com
• Phone: +1(866)789-2211
• Email: pvnorthamerica@curiumpharma.com
• Phone: +1(866)789-2211
• Email: pvnorthamerica@curiumpharma.com
• Phone: +1(866)789-2211
• Email: pvnorthamerica@curiumpharma.com
• Phone: +1(866)789-2211
• Email: pvnorthamerica@curiumpharma.com
• Phone: +1(866)789-2211
• Email: pvnorthamerica@curiumpharma.com
• Phone: +1(866)789-2211
• Email: pvnorthamerica@curiumpharma.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00369945000019 [Primary]

FDA Product Code

• CCQ: Nebulizer, Medicinal, Non-Ventilatory (Atomizer)

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: 2023-09-01
• Device Publish Date: 2023-08-24

Devices Manufactured by CURIUM US LLC

• 00369945000019 - Ultravent: 2023-09-01Ultravent Radioaerosol Delivery System
• 00369945000019 - Ultravent: 2023-09-01 Ultravent Radioaerosol Delivery System
• 00369945000002 - Xenotron: 2020-02-10 Xenon (Xe 133) Gas Dispenser