Innospire Deluxe

GUDID 16946159502068

1110064

VEGA TECHNOLOGIES INC.

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• Primary Device ID: 16946159502068
• NIH Device Record Key: a8312b06-9cce-4841-aca2-55c0f1165253
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Innospire Deluxe
• Version Model Number: 1110064
• 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	06946159502061 [Primary]
GS1	16946159502068 [Package]; Contains: 06946159502061; 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 [Innospire Deluxe]

• 16946159502129: 1131761
• 16946159502112: 1110061
• 16946159502105: 1110060
• 16946159500095: 1110058
• 16946159502082: 1110057
• 16946159502075: 1110059
• 16946159502068: 1110064
• 16946159502051: 1110066
• 16946159502044: 1110063
• 16946159502037: 1110062
• 16946159502020: 1112279
• 16946159502013: 1112278