Infusion Sets, Bien Air

GUDID J00715016350011

Irrigation Line KM (10/pkg)

OMNIA SRL

Disposable surgical irrigation/aspiration system

• Primary Device ID: J00715016350011
• NIH Device Record Key: c5a18ccd-6c03-45c9-84f8-02cf07618701
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Infusion Sets, Bien Air
• Version Model Number: 1501635-010
• Company DUNS: 447696675
• Company Name: OMNIA SRL
• Device Count: 10
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• 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: false

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	J00715016350011 [Unit of Use]
HIBCC	J00715016350101 [Primary]

FDA Product Code

• EFS: Unit, Oral Irrigation

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-10-14
• Device Publish Date: 2021-10-06

On-Brand Devices [Infusion Sets, Bien Air]

• 08056646503889: Irrigation Line KM (10/pkg)
• 08056646503865: Irrigation Line (10/pkg)
• J00715016350011: Irrigation Line KM (10/pkg)
• J00715009840101: Irrigation Line (10/pkg)