Catalog Number

-

Brand Name

Impedance/pH, 6 imp channels, 1 pH antimony, LES locator

Version/Model Number

MMS-Z1-A-LES

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code

FFX

Product Code Name

SYSTEM, GASTROINTESTINAL MOTILITY (ELECTRICAL)

Public Device Record Key

5837e879-9349-4c48-a443-42854bef9998

Public Version Date

October 19, 2020

Public Version Number

4

DI Record Publish Date

September 23, 2016

Package DI Number

08717775954088

Quantity per Package

5

Contains DI Package

08717775954071

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-