Catalog Number

017352

Brand Name

Extravasation Detection Patch with Access Slot

Version/Model Number

017352

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

-

Product Code

DSB

Product Code Name

Plethysmograph, Impedance

Public Device Record Key

aa247bbd-cb8e-4e54-b256-d896639fde61

Public Version Date

November 06, 2020

Public Version Number

4

DI Record Publish Date

September 20, 2016

Package DI Number

27630039300344

Quantity per Package

25

Contains DI Package

17630039300347

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box