Catalog Number

IM7088FR0

Brand Name

MUC-X

Version/Model Number

8 French

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

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

K893204,K893204

Product Code

BSY

Product Code Name

Catheters, Suction, Tracheobronchial

Public Device Record Key

76b6b918-1a8c-4bb5-989d-e95d0da6592e

Public Version Date

June 12, 2020

Public Version Number

1

DI Record Publish Date

June 04, 2020

Package DI Number

H671IM7088FR1

Quantity per Package

25

Contains DI Package

H671IM7088FR0

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-