Catalog Number

-

Brand Name

EXTRA LOW FLOW GAS TUBE

Version/Model Number

MAJ-1816

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

K063786

Product Code

FCX

Product Code Name

INSUFFLATOR, AUTOMATIC CARBON-DIOXIDE FOR ENDOSCOPE

Public Device Record Key

a1825cea-5e89-4919-89d1-e7dd6527482f

Public Version Date

June 10, 2022

Public Version Number

7

DI Record Publish Date

September 21, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-