Duns Number:656854379
Catalog Number
GiO Digital Pressure Gauge, 0~80cmH O
Brand Name
JITTO
Version/Model Number
GB20
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
921909bb-f64f-4a63-8cef-f82964b2e510
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
October 15, 2015
Package DI Number
44710810119888
Quantity per Package
4
Contains DI Package
24710810119884
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Carton
Device Class | Device Class Description | No of Devices |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 29 |
2 | A medical device with a moderate to high risk that requires special controls. | 22 |