Patient Circuit - Adult, 1.8m, 1 pcs, one way

GUDID 17290017096763

INOVYTEC MEDICAL SOLUTIONS LTD

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• Primary Device ID: 17290017096763
• NIH Device Record Key: d84229a7-04e3-4df0-8ba8-891e3c29b017
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Patient Circuit - Adult, 1.8m, 1 pcs, one way
• Version Model Number: VWSP-450F
• Company DUNS: 649213584
• Company Name: INOVYTEC MEDICAL SOLUTIONS 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: 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: +97299656485
• Email: info@inovytec.com
• Phone: +97299656485
• Email: info@inovytec.com
• Phone: +97299656485
• Email: info@inovytec.com
• Phone: +97299656485
• Email: info@inovytec.com
• Phone: +97299656485
• Email: info@inovytec.com
• Phone: +97299656485
• Email: info@inovytec.com
• Phone: +97299656485
• Email: info@inovytec.com
• Phone: +97299656485
• Email: info@inovytec.com
• Phone: +97299656485
• Email: info@inovytec.com
• Phone: +97299656485
• Email: info@inovytec.com
• Phone: +97299656485
• Email: info@inovytec.com
• Phone: +97299656485
• Email: info@inovytec.com
• Phone: +97299656485
• Email: info@inovytec.com
• Phone: +97299656485
• Email: info@inovytec.com
• Phone: +97299656485
• Email: info@inovytec.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	07290017096766 [Primary]
GS1	17290017096763 [Package]; Contains: 07290017096766; Package: [10 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K202970

FDA Product Code

• CBK: Ventilator, Continuous, Facility Use

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2023-07-06
• Device Publish Date: 2023-01-11

Devices Manufactured by INOVYTEC MEDICAL SOLUTIONS LTD

• 17290017096763 - Patient Circuit - Adult, 1.8m, 1 pcs, one way: 2023-07-06
• 17290017096763 - Patient Circuit - Adult, 1.8m, 1 pcs, one way: 2023-07-06
• 17290017096770 - Patient Circuit - Pediatric, 1.8m, 1 pcs, one way: 2023-07-06
• 07290017096889 - Patient Circuit - Adult, 2.4m, 1 pcs: 2023-07-06
• 07290017096902 - Patient Circuit - Pediatric, 2.4m, 1 pcs: 2023-07-06