Catalog Number

M9000-SEFD

Brand Name

ICU Medical

Version/Model Number

M9000-SEFD

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

e474b17c-86e4-40eb-87ef-d351ebc1e8af

Public Version Date

September 21, 2022

Public Version Number

1

DI Record Publish Date

September 13, 2022

Package DI Number

10887709098258

Quantity per Package

50

Contains DI Package

00887709098251

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

BOX