Spirometer

GUDID 06934325302294

FEELLIFE HEALTH INC.

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• Primary Device ID: 06934325302294
• NIH Device Record Key: 1c5fdc18-2d85-47cb-b06f-43fe5d168507
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Spirometer
• Version Model Number: Air Smart Extra
• Company DUNS: 544431678
• Company Name: FEELLIFE HEALTH INC.
• 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: false
• 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	06934325302294 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K222443

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: 2023-09-27
• Device Publish Date: 2023-09-19

Devices Manufactured by FEELLIFE HEALTH INC.

• 06934325302294 - Spirometer: 2023-09-27
• 06934325302294 - Spirometer: 2023-09-27
• 06934325303741 - Mouthpiece: 2023-02-22
• 06934325303758 - Disposable Mouthpiece: 2023-02-22
• 06934325303765 - Pressure gas blowpipe: 2023-02-22
• 06934325302249 - Portable Mesh Nebulizer: 2023-02-16
• 06934325302263 - Portable Mesh Nebulizer: 2023-02-16
• 06934325301846 - Portable Mesh Nebulizer: 2022-10-17
• 06934325319490 - Portable Mesh Nebulizer: 2021-08-27