Catalog Number

292-U400CD

Brand Name

U400 ImpSoft Software

Version/Model Number

2.2.0

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

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

-

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

K080825,K080825,K080825

Product Code

OBH

Product Code Name

Monitor, Extracellular Fluid, Lymphedema, Extremity

Public Device Record Key

23776b58-b860-4ea9-ab8c-f1454c5f8082

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

February 13, 2017

Package DI Number

B277292U400CD2

Quantity per Package

1

Contains DI Package

B277292U400CD1

Package Discontinue Date

-

Package Status

-

Package Type

CD Sleeve