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 |
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 |
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 |