Phlips Home Nebulizer

GUDID 16946159503010

1130529

VEGA TECHNOLOGIES INC.

Medical device air compressor

• Primary Device ID: 16946159503010
• NIH Device Record Key: e436f958-6d98-466d-976b-cda153ee39cb
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Phlips Home Nebulizer
• Version Model Number: 1130529
• 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	06946159503013 [Primary]
GS1	16946159503010 [Package]; Contains: 06946159503013; 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

Devices Manufactured by VEGA TECHNOLOGIES INC.

• 16946159500217 - VEGA: 2024-05-21
• 06946159505024 - VEGA: 2023-11-13 MT-218
• 06946159501484 - VEGA: 2023-09-11
• 06946159501019 - Sami the Seal: 2018-07-02 1093235
• 16946159501023 - Sami the Seal: 2018-07-02 1093270
• 16946159501030 - Sami the Seal: 2018-07-02 1093237
• 16946159501047 - Sami the Seal: 2018-07-02 1093268
• 16946159501054 - Sami the Seal: 2018-07-02 1082456