none

GUDID 06971919466949

Ningbo Albert Novosino Co.,Ltd.

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