OnGuard®2 20mm Vial Adaptor II and 13mm convertor

GUDID 17290115921714

OnGuard2 20mm Vial Adaptor is part of the Chemfort CSTD system. The device distal end is intended to connect to 20mm neck drug vial The device proximal end is intended to connect to OnGuard2 Syringe Adaptor / Syringe Adaptor Lock

SIMPLIVIA HEALTHCARE LTD

Medication transfer set

• Primary Device ID: 17290115921714
• NIH Device Record Key: a65e7c6b-64d9-485a-9c07-61af07c193a9
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: OnGuard®2 20mm Vial Adaptor II and 13mm convertor
• Version Model Number: 412171
• Company DUNS: 521161349
• Company Name: SIMPLIVIA HEALTHCARE LTD
• Device Count: 50
• 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: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +97246909710
• Email: customer.service@simplivia.com
• Phone: +97246909710
• Email: customer.service@simplivia.com
• Phone: +97246909710
• Email: customer.service@simplivia.com
• Phone: +97246909710
• Email: customer.service@simplivia.com
• Phone: +97246909710
• Email: customer.service@simplivia.com
• Phone: +97246909710
• Email: customer.service@simplivia.com
• Phone: +97246909710
• Email: customer.service@simplivia.com
• Phone: +97246909710
• Email: customer.service@simplivia.com
• Phone: +97246909710
• Email: customer.service@simplivia.com
• Phone: +97246909710
• Email: customer.service@simplivia.com
• Phone: +97246909710
• Email: customer.service@simplivia.com
• Phone: +97246909710
• Email: customer.service@simplivia.com
• Phone: +97246909710
• Email: customer.service@simplivia.com
• Phone: +97246909710
• Email: customer.service@simplivia.com
• Phone: +97246909710
• Email: customer.service@simplivia.com
• Phone: +97246909710
• Email: customer.service@simplivia.com
• Phone: +97246909710
• Email: customer.service@simplivia.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	17290115921714 [Unit of Use]
GS1	27290115921711 [Primary]
GS1	37290115921718 [Package]; Contains: 27290115921711; Package: [4 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K192866

FDA Product Code

• ONB: Closed Antineoplastic And Hazardous Drug Reconstitution And Transfer System

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: 2024-09-23
• Device Publish Date: 2024-09-15

Devices Manufactured by SIMPLIVIA HEALTHCARE LTD

• 17290115921714 - OnGuard®2 20mm Vial Adaptor II and 13mm convertor: 2024-09-23OnGuard2 20mm Vial Adaptor is part of the Chemfort CSTD system. The device distal end is intended to connect to 20mm neck drug vial The device proximal end is intended to connect to OnGuard2 Syringe Adaptor / Syringe Adaptor Lock
• 17290115921714 - OnGuard®2 20mm Vial Adaptor II and 13mm convertor: 2024-09-23 OnGuard2 20mm Vial Adaptor is part of the Chemfort CSTD system. The device distal end is intended to connect to 20mm neck drug
• 37290115921756 - OnGuard2 20mm Vial Adaptor, 10 Units: 2024-09-16 OnGuard2 Vial Adaptor,10 Units is part of the Chemfort CSTD system. The device distal end is intended to connect to 20mm neck d
• 37290115921879 - OnGuard2 20mm Vial Adaptor, 5 Units: 2024-09-16 OnGuard2 Vial Adaptor, 5 Units is part of the Chemfort CSTD system. The device distal end is intended to connect to 20mm neck d
• 37290115921886 - OnGuard2 Syringe Adaptor, 5 Units: 2024-09-16 OnGuard2 Syringe Adaptor, 5 Units is part of the Chemfort CSTD system. The device distal end is intended to connect to Chemfort
• 37290115921893 - OnGuard2 Syringe Adaptor Lock II, 5 Units: 2024-09-16 OnGuard2 Syringe Adaptor Lock II, 5 Units is part of the Chemfort CSTD system. The device distal end is intended to connect to
• 17290115921868 - OnGuard2 Bag Adaptor SP II: 2024-05-14 OnGuard2 CSTD Bag Adaptor SP II a Chemfort Product
• 37290115921145 - OnGuard Luer Lock Adaptor: 2022-10-11 The Luer Lock Adaptor is part of the OnGuard CSTD system. The proximal end connects to female luer lock of the IV set. The OnG
• 37290115921138 - OnGuard Spike Port Adaptor: 2022-10-11 The Spike Port Adaptor is part of the OnGuard CSTD system. The devices spike connects to IV solution container. The proximal end