Catalog Number

GiO Digital Pressure Gauge, -60~0 cmH O

Brand Name

JITTO

Version/Model Number

GB40

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

K122627,K122627,K122627

Product Code

CAP

Product Code Name

Monitor, Airway Pressure (Includes Gauge And/Or Alarm)

Public Device Record Key

058abe18-3627-4fd0-bf7a-183baa5bd7e4

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

October 15, 2015

Package DI Number

44710810119901

Quantity per Package

4

Contains DI Package

24710810119907

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Carton