Pedi-Neb Nasal Nebulizer

GUDID 10709078001601

VixOne Nebullzer and attached pacifier

WESTMED, INC.

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

• Primary Device ID: 10709078001601
• NIH Device Record Key: 19e668d1-8ebf-41b9-89e1-a7880042ca4d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Pedi-Neb Nasal Nebulizer
• Version Model Number: 0384
• Company DUNS: 092673953
• Company Name: WESTMED, INC.
• 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: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00709078001604 [Primary]
GS1	10709078001601 [Package]; Contains: 00709078001604; Package: [250 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K800562

FDA Product Code

• CAF: Nebulizer (Direct Patient Interface)

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-11-24

On-Brand Devices [Pedi-Neb Nasal Nebulizer]

• 10709078001618: VixOne Nebullzer and attached pacifier
• 10709078001601: VixOne Nebullzer and attached pacifier
• 10709078001595: VixOne Nebullzer and attached pacifier
• 00709078001581: VixOne Nebullzer and attached pacifier