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GUDID 06971919466949

Ningbo Albert Novosino Co.,Ltd.

Middle ear decompressor, positive pressure Middle ear decompressor, positive pressure Middle ear decompressor, positive pressure Middle ear decompressor, positive pressure Middle ear decompressor, positive pressure Middle ear decompressor, positive pressure Middle ear decompressor, positive pressure Middle ear decompressor, positive pressure Middle ear decompressor, positive pressure Middle ear decompressor, positive pressure Middle ear decompressor, positive pressure Middle ear decompressor, positive pressure Middle ear decompressor, positive pressure Middle ear decompressor, positive pressure Middle ear decompressor, positive pressure Middle ear decompressor, positive pressure Middle ear decompressor, positive pressure Middle ear decompressor, positive pressure

• Primary Device ID: 06971919466949
• NIH Device Record Key: 6fde2c0b-9dea-4cb2-8723-2ba1f6ab955e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: none
• Version Model Number: ER813B
• Company DUNS: 543014978
• Company Name: Ningbo Albert Novosino Co.,Ltd.
• 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: false
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: true

Device Identifiers

Device Issuing Agency	Device ID
GS1	06971919466949 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K230502

FDA Product Code

• MJV: Device, Inflation, Middle Ear

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: 2023-11-03
• Device Publish Date: 2023-10-26

On-Brand Devices [none]

• 06971919469063: 1.0
• 06971919469056: 1.0
• 06971919469049: 1.0
• 06971919469032: 1.0
• 06971919460817: ED816
• 06971919466949: ER813B