| Primary Device ID | 37290115921138 |
| NIH Device Record Key | fe6ea7b9-523b-408a-a3eb-5f679893fb1b |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | OnGuard Spike Port Adaptor |
| Version Model Number | 412113 |
| 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 | 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 |
| Phone | +97246909710 |
| customer.service@simplivia.com | |
| Phone | +97246909710 |
| customer.service@simplivia.com | |
| Phone | +97246909710 |
| customer.service@simplivia.com | |
| Phone | +97246909710 |
| customer.service@simplivia.com | |
| Phone | +97246909710 |
| customer.service@simplivia.com | |
| Phone | +97246909710 |
| customer.service@simplivia.com | |
| Phone | +97246909710 |
| customer.service@simplivia.com | |
| Phone | +97246909710 |
| customer.service@simplivia.com | |
| Phone | +97246909710 |
| customer.service@simplivia.com | |
| Phone | +97246909710 |
| customer.service@simplivia.com |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 17290115921134 [Unit of Use] |
| GS1 | 37290115921138 [Primary] |
| ONB | Closed Antineoplastic And Hazardous Drug Reconstitution And Transfer System |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2022-10-11 |
| Device Publish Date | 2022-10-03 |
| 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 | 2022-10-11The Spike Port Adaptor is part of the OnGuard CSTD system. The devices spike connects to IV solution container. The proximal end connects to IV set spike, to allow administration. The port connects to OnGuard2 Syringe Adaptor to transfer drug or withdraw saline / drug. |
| 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 |