Catalog Number

M9000-U

Brand Name

ICU Medical

Version/Model Number

M9000-U

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"

Yes

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

K915171,K915171

Product Code

KNT

Product Code Name

Tubes, gastrointestinal (and accessories)

Public Device Record Key

8563f1e1-bb7f-43a9-ab75-3f7c8c43ff2e

Public Version Date

September 01, 2021

Public Version Number

1

DI Record Publish Date

August 24, 2021

Package DI Number

10887709037134

Quantity per Package

100

Contains DI Package

00887709037137

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CS