Philips Home Nebulizer

GUDID 16946159503096

1138619

VEGA TECHNOLOGIES INC.

Medical device air compressor

• Primary Device ID: 16946159503096
• NIH Device Record Key: 0e5526ed-c630-4be1-9db8-97aed31b7fb1
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Philips Home Nebulizer
• Version Model Number: 1138619
• Company DUNS: 421290561
• Company Name: VEGA TECHNOLOGIES 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: false
• Lot Batch: true
• 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: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	06946159503099 [Primary]
GS1	16946159503096 [Package]; Contains: 06946159503099; Package: [6 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K031413

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: 2018-07-02
• Device Publish Date: 2018-06-01

On-Brand Devices [Philips Home Nebulizer]

• 16946159503096: 1138619
• 16946159503089: 1138634
• 16946159503072: 1138635
• 16946159503065: 1138618
• 16946159503058: 1136915
• 16946159503034: 1130531
• 16946159503027: 1130530