ONGUARD2 20mm VIAL ADAPTOR SL with 13 mm convertor - Part of the Chemfort OnGuard2 system - SIMPLIVIA HEALTHCARE LTD

Duns Number:521161349

Device Description: Part of the Chemfort OnGuard2 system

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More Product Details

Catalog Number

-

Brand Name

ONGUARD2 20mm VIAL ADAPTOR SL with 13 mm convertor

Version/Model Number

412170

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

Labeling does not contain MRI Safety Information

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

-

Device labeled as "Not made with natural rubber latex"

Yes

For Single-Use

Yes

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K192866,K192866,K192866

Product Code Details

Product Code

ONB

Product Code Name

Closed Antineoplastic And Hazardous Drug Reconstitution And Transfer System

Device Record Status

Public Device Record Key

bc62bb31-a560-4fc5-b33e-ea9f195192f1

Public Version Date

October 18, 2021

Public Version Number

1

DI Record Publish Date

October 10, 2021

Additional Identifiers

Package DI Number

37290115921701

Quantity per Package

4

Contains DI Package

27290115921704

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-

"SIMPLIVIA HEALTHCARE LTD" Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 11