OnGuard2 Syringe Adaptor Sterile Replacement Cap

GUDID 37290115921770

Sterile Replacement Cap for OnGuard2 Syringe Adaptor or Syringe Adaptor Lock

SIMPLIVIA HEALTHCARE LTD

Medication transfer set
Primary Device ID37290115921770
NIH Device Record Key21cf75c2-9f87-4678-a0b9-9c0ef76c0221
Commercial Distribution StatusIn Commercial Distribution
Brand NameOnGuard2 Syringe Adaptor Sterile Replacement Cap
Version Model Number412177
Company DUNS521161349
Company NameSIMPLIVIA HEALTHCARE LTD
Device Count100
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
GS117290115921776 [Unit of Use]
GS127290115921773 [Primary]
GS137290115921770 [Package]
Contains: 27290115921773
Package: [400 Units]
In Commercial Distribution

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 Date2022-09-05
Device Publish Date2022-08-28

Devices Manufactured by SIMPLIVIA HEALTHCARE LTD

17290115921714 - OnGuard®2 20mm Vial Adaptor II and 13mm convertor2024-09-23 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 Units2024-09-16 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 Units2024-09-16 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 Units2024-09-16 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 Units2024-09-16 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 II2024-05-14 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 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

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