Catalog Number

MG412120

Brand Name

TEVADAPTOR® Secondary IV Administration Set with ULTRASITE® Inj. Site

Version/Model Number

MG412120

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

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)

-

Over the Counter (OTC)

Yes

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K121269,K121269

Product Code

FPA

Product Code Name

Set, administration, intravascular

Public Device Record Key

1080b927-217c-484c-9367-54502bfd252d

Public Version Date

April 07, 2021

Public Version Number

5

DI Record Publish Date

September 15, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-