Spiro Handle

GUDID 18809276943726

SPIROMETER, DIAGNOSTIC

Bionet CO,LTD

Diagnostic spirometer Diagnostic spirometer Diagnostic spirometer Diagnostic spirometer Diagnostic spirometer Diagnostic spirometer Diagnostic spirometer Diagnostic spirometer Diagnostic spirometer Diagnostic spirometer Diagnostic spirometer Diagnostic spirometer Diagnostic spirometer Diagnostic spirometer Diagnostic spirometer Diagnostic spirometer, professional Diagnostic spirometer, professional Diagnostic spirometer, professional Diagnostic spirometer, professional Diagnostic spirometer, professional Diagnostic spirometer, professional Diagnostic spirometer, professional Diagnostic spirometer, professional Diagnostic spirometer, professional Diagnostic spirometer, professional Diagnostic spirometer, professional Diagnostic spirometer, professional Diagnostic spirometer, professional Diagnostic spirometer, professional Diagnostic spirometer, professional Diagnostic spirometer, professional

• Primary Device ID: 18809276943726
• NIH Device Record Key: a0732f86-9aaa-46fc-a293-ced6827a76f4
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Spiro Handle
• Version Model Number: Spiro Handle
• Company DUNS: 689708212
• Company Name: Bionet CO,LTD
• 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: false
• Serial Number: true
• Manufacturing Date: true
• 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	08809276943729 [Primary]
GS1	18809276943726 [Package]; Contains: 08809276943729; Package: Box [4 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K130322

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: 2021-07-23
• Device Publish Date: 2021-07-15

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• 18809276943726 - Spiro Handle: 2021-07-23SPIROMETER, DIAGNOSTIC
• 18809276943726 - Spiro Handle: 2021-07-23 SPIROMETER, DIAGNOSTIC