| Primary Device ID | 37290115921701 |
| NIH Device Record Key | bc62bb31-a560-4fc5-b33e-ea9f195192f1 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | ONGUARD2 20mm VIAL ADAPTOR SL with 13 mm convertor |
| Version Model Number | 412170 |
| 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 |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 17290115921707 [Unit of Use] |
| GS1 | 27290115921704 [Primary] |
| GS1 | 37290115921701 [Package] Contains: 27290115921704 Package: [4 Units] In Commercial Distribution |
| 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 | 2021-10-18 |
| Device Publish Date | 2021-10-10 |
| 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 |