Duns Number:112569116
Device Description: 1900 SERIES,REG,02,EP5,870,GAUGE,OG
Catalog Number
-
Brand Name
Easy Pulse II Oxygen Conserver
Version/Model Number
198705OG
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
-
Product Code
CAW
Product Code Name
Generator, Oxygen, Portable
Public Device Record Key
3353c0db-7662-462c-86ba-9a450a62e7dd
Public Version Date
October 11, 2021
Public Version Number
2
DI Record Publish Date
September 29, 2020
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
Device Class | Device Class Description | No of Devices |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 23 |
2 | A medical device with a moderate to high risk that requires special controls. | 106 |