OnGuard 2 CSTD IV Secondary Safety

GUDID 17290115921653

A Chemfort CSTD Product

SIMPLIVIA HEALTHCARE LTD

Medication transfer set Medication transfer set Medication transfer set Medication transfer set Medication transfer set Medication transfer set Medication transfer set Medication transfer set Medication transfer set Medication transfer set Medication transfer set Medication transfer set Medication transfer set Medication transfer set
Primary Device ID17290115921653
NIH Device Record Key54d5ae1d-04fd-4da3-99e4-54dc46c97f51
Commercial Distribution StatusIn Commercial Distribution
Brand NameOnGuard 2 CSTD IV Secondary Safety
Version Model Number412165
Company DUNS521161349
Company NameSIMPLIVIA HEALTHCARE LTD
Device Count50
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numbertrue
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+97246909710
Emailcustomer.service@simplivia.com
Phone+97246909710
Emailcustomer.service@simplivia.com
Phone+97246909710
Emailcustomer.service@simplivia.com
Phone+97246909710
Emailcustomer.service@simplivia.com
Phone+97246909710
Emailcustomer.service@simplivia.com
Phone+97246909710
Emailcustomer.service@simplivia.com
Phone+97246909710
Emailcustomer.service@simplivia.com
Phone+97246909710
Emailcustomer.service@simplivia.com
Phone+97246909710
Emailcustomer.service@simplivia.com
Phone+97246909710
Emailcustomer.service@simplivia.com
Phone+97246909710
Emailcustomer.service@simplivia.com
Phone+97246909710
Emailcustomer.service@simplivia.com
Phone+97246909710
Emailcustomer.service@simplivia.com
Phone+97246909710
Emailcustomer.service@simplivia.com

Device Identifiers

Device Issuing AgencyDevice ID
GS117290115921653 [Unit of Use]
GS137290115921657 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

ONBClosed Antineoplastic And Hazardous Drug Reconstitution And Transfer System

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-03-19
Device Publish Date2021-03-11

Devices Manufactured by SIMPLIVIA HEALTHCARE LTD

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 Adaptor2022-10-11 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 Cap2022-09-05 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 II2022-02-28 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 SP2021-10-25 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 Set2021-10-25 For use with Chemfort OnGuard CSTD The product is part of OnGurd2 Chemfort Closed Administration The Closed Y Inline Set conne

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