Air Next

GUDID 07350002630006

NuvoAir AB

Diagnostic spirometer, professional

• Primary Device ID: 07350002630006
• NIH Device Record Key: d64b818e-6eeb-412f-ab0b-3c52dde95fe5
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Air Next
• Version Model Number: NVD-02
• Company DUNS: 352418477
• Company Name: NuvoAir AB
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Unsafe
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	07350002630006 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K231416

FDA Product Code

• BZG: Spirometer, Diagnostic

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: 2024-03-28
• Device Publish Date: 2024-03-20

On-Brand Devices [Air Next]

• 17350002630027: NVD-01
• 07350002630006: NVD-02