Primary Device ID | 17290115921653 |
NIH Device Record Key | 54d5ae1d-04fd-4da3-99e4-54dc46c97f51 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | OnGuard 2 CSTD IV Secondary Safety |
Version Model Number | 412165 |
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 | 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 |
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 | |
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 | 17290115921653 [Unit of Use] |
GS1 | 37290115921657 [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 | 2021-03-19 |
Device Publish Date | 2021-03-11 |
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 |
37290115921770 - OnGuard2 Syringe Adaptor Sterile Replacement Cap | 2022-09-05 Sterile Replacement Cap for OnGuard2 Syringe Adaptor or Syringe Adaptor Lock |
17290115921813 - Catheter Adaptor | 2022-07-12 The Catheter Adaptor distal end is attached to a tube The Catheter Adaptor proximal end is attached to OnGuard / OnGuard2 Syring |
37290115921749 - OnGuard2 Syringe Adaptor Lock II | 2022-02-28 The product is part of OnGurd2 Chemfort system For use with Chemfort OnGuard2 CSTD The distal end of Syringe Adaptor Lock II ca |
37290115921664 - OnGuard2 Chemfort Bag Adaptor CP | 2021-10-25 For use with Chemfort OnGuard CSTD The product is part of OnGurd2 Chemfort Closed Administration (CADM) The Bag Adaptor CP con |
37290115921695 - OnGuard2 Chemfort Closed Adaptor SP | 2021-10-25 For use with Chemfort OnGuard CSTD The product is part of OnGurd2 Chemfort Closed Administration The Closed Adaptor SP connect |
17290115921677 - OnGuard2 Chemfort Closed Y Inline Set | 2021-10-25 For use with Chemfort OnGuard CSTD The product is part of OnGurd2 Chemfort Closed Administration The Closed Y Inline Set conne |