VIROBAC II® 20802

GUDID 00612649215419

VII VIRAL/BACTERIAL EXHALATION FILTER

King Systems Corporation

Microbial medical gas filter, single-use

• Primary Device ID: 00612649215419
• NIH Device Record Key: 72e1d1b2-4251-4872-b827-4500fb155b85
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: VIROBAC II®
• Version Model Number: 20802
• Catalog Number: 20802
• Company DUNS: 009299017
• Company Name: King Systems Corporation
• 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: 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: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +14107686464
• Email: Purchase_orders@ambuUSA.com
• Phone: +14107686464
• Email: Purchase_orders@ambuUSA.com
• Phone: +14107686464
• Email: Purchase_orders@ambuUSA.com
• Phone: +14107686464
• Email: Purchase_orders@ambuUSA.com
• Phone: +14107686464
• Email: Purchase_orders@ambuUSA.com
• Phone: +14107686464
• Email: Purchase_orders@ambuUSA.com
• Phone: +14107686464
• Email: Purchase_orders@ambuUSA.com
• Phone: +14107686464
• Email: Purchase_orders@ambuUSA.com
• Phone: +14107686464
• Email: Purchase_orders@ambuUSA.com
• Phone: +14107686464
• Email: Purchase_orders@ambuUSA.com
• Phone: +14107686464
• Email: Purchase_orders@ambuUSA.com
• Phone: +14107686464
• Email: Purchase_orders@ambuUSA.com
• Phone: +14107686464
• Email: Purchase_orders@ambuUSA.com
• Phone: +14107686464
• Email: Purchase_orders@ambuUSA.com
• Phone: +14107686464
• Email: Purchase_orders@ambuUSA.com
• Phone: +14107686464
• Email: Purchase_orders@ambuUSA.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00612649215419 [Package]; Contains: 00612649215426; Package: [50 Units]; In Commercial Distribution
GS1	00612649215426 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K880681

FDA Product Code

• CAH: Filter, bacterial, breathing-circuit

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: 2021-05-28
• Device Publish Date: 2021-05-20

Devices Manufactured by King Systems Corporation

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• 00612649216980 - UNIVERSAL FLEX2®BREATHING CIRCUIT: 2024-12-09 UNIVERSAL FLEX2 CIRCUIT
• 00612649217000 - UNIVERSAL FLEX2®: 2024-12-09 UNIVERSAL FLEX2 CIRCUIT
• 00612649217024 - UNIVERSAL FLEX2®: 2024-12-09 UNIVERSAL FLEX2 CIRCUIT
• 00612649217048 - UNIVERSAL FLEX2®: 2024-12-09 UNIVERSAL FLEX2 CIRCUIT
• 00612649217062 - UNIVERSAL FLEX2®: 2024-12-09 UNIVERSAL FLEX2 CIRCUIT
• 00612649217086 - UNIVERSAL FLEX2®: 2024-12-09 UNIVERSAL FLEX2 CIRCUIT