Phlips Home Nebulizer

GUDID 16946159503010

1130529

VEGA TECHNOLOGIES INC.

Medical device air compressor Medical device air compressor Medical device air compressor Medical device air compressor Medical device air compressor Medical device air compressor Medical device air compressor Medical device air compressor Medical device air compressor Medical device air compressor Medical device air compressor Medical device air compressor Medical device air compressor Medical device air compressor Medical device air compressor 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.

• 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
• 16946159501061 - Sami the Seal: 2018-07-02 1082731