Catalog Number

KIP-II-RS

Brand Name

ReShape Infiltration Pump

Version/Model Number

KIP-II-RS

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

August 10, 2020

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

-

Prescription Use (Rx)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K031432,K031432

Product Code

FRN

Product Code Name

Pump, Infusion

Public Device Record Key

e957b043-c890-47ae-b5b0-e80cffbced69

Public Version Date

July 04, 2022

Public Version Number

4

DI Record Publish Date

June 16, 2020

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-