Catalog Number

GiO Digital Pressure Gauge, -30~100 cmHO

Brand Name

JITTO

Version/Model Number

GB30

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

8d5168a9-12ce-4f25-8ff8-49d107526a1a

Public Version Date

April 21, 2020

Public Version Number

4

DI Record Publish Date

October 15, 2015

Package DI Number

24710810105252

Quantity per Package

10

Contains DI Package

04710810105258

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box