Catalog Number

515510010010

Brand Name

GEM FLOW COUPLER AC Power Supply Kit, US

Version/Model Number

GEM1010US

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

-

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

K093310

Product Code

DPW

Product Code Name

FLOWMETER, BLOOD, CARDIOVASCULAR

Public Device Record Key

3f7bd469-9891-4a05-ae09-4ac906e1f76e

Public Version Date

October 11, 2022

Public Version Number

4

DI Record Publish Date

September 24, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-