OnGuard®2 CSTD Bag Adaptor SP

GUDID 37290115921435

OnGuard®2 CSTD Bag Adaptor SP A Chemfort CSTD Product

SIMPLIVIA HEALTHCARE LTD

Medication transfer set

• Primary Device ID: 37290115921435
• NIH Device Record Key: a06fece9-303b-41c1-9524-8ac4eeaeb939
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: OnGuard®2 CSTD Bag Adaptor SP
• Version Model Number: 412143
• Company DUNS: 521161349
• Company Name: SIMPLIVIA HEALTHCARE LTD
• Device Count: 100
• 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: true
• 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: +97246908710
• Email: rona.pollak@simplivia.com
• Phone: +97246908710
• Email: rona.pollak@simplivia.com
• Phone: +97246908710
• Email: rona.pollak@simplivia.com
• Phone: +97246908710
• Email: rona.pollak@simplivia.com
• Phone: +97246908710
• Email: rona.pollak@simplivia.com
• Phone: +97246908710
• Email: rona.pollak@simplivia.com
• Phone: +97246908710
• Email: rona.pollak@simplivia.com
• Phone: +97246908710
• Email: rona.pollak@simplivia.com
• Phone: +97246908710
• Email: rona.pollak@simplivia.com
• Phone: +97246908710
• Email: rona.pollak@simplivia.com
• Phone: +97246908710
• Email: rona.pollak@simplivia.com
• Phone: +97246908710
• Email: rona.pollak@simplivia.com
• Phone: +97246908710
• Email: rona.pollak@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	17290115921431 [Unit of Use]
GS1	27290115921438 [Primary]
GS1	37290115921435 [Package]; Contains: 27290115921438; Package: [2 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: 2020-07-20
• Device Publish Date: 2020-07-12

Devices Manufactured by SIMPLIVIA HEALTHCARE LTD

• 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