Catalog Number

GiO Digital Pressure Gauge, -30~100 cmHO

Brand Name

JITTO

Version/Model Number

GB30

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

April 20, 2020

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

Product Code

CAP

Product Code Name

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

Public Device Record Key

3cffe4b6-a5e9-4c90-ac0f-81c54432a861

Public Version Date

April 21, 2020

Public Version Number

2

DI Record Publish Date

August 01, 2019

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-