Catalog Number

5150-002

Brand Name

Model 5150-002 Tubing Set

Version/Model Number

5150-002

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"

-

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

K912447

Product Code

FET

Product Code Name

Endoscopic Video Imaging System/Component, Gastroenterology-Urology

Public Device Record Key

1f6f9ea9-9396-49a0-9a72-4edeccd0addd

Public Version Date

April 23, 2019

Public Version Number

5

DI Record Publish Date

September 22, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-