Catalog Number

-

Brand Name

Exoflex 10.5in. IVExtension Set

Version/Model Number

95781

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"

-

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

K162304

Product Code

FPA

Product Code Name

Set, Administration, Intravascular

Public Device Record Key

a94487ee-68f9-472a-9339-c3c2834363b1

Public Version Date

December 17, 2019

Public Version Number

1

DI Record Publish Date

December 09, 2019

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-