Catalog Number

FLT-112S

Brand Name

Fluent Fluid Management System

Version/Model Number

FLT-112S

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K180825,K180825,K180825

Product Code

HIG

Product Code Name

INSUFFLATOR, HYSTEROSCOPIC

Public Device Record Key

d7b5f038-95e3-4324-b562-c5094ef8b240

Public Version Date

September 28, 2018

Public Version Number

1

DI Record Publish Date

August 28, 2018

Package DI Number

35420045507405

Quantity per Package

1

Contains DI Package

15420045507401

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

BOX