Duns Number:926603486
Device Description: is a device used in medicine to assist in the delivery of oxygen therapy.
Catalog Number
DU1060
Brand Name
Non-rebreather mask
Version/Model Number
1
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"
Yes
For Single-Use
Yes
Prescription Use (Rx)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
KGB
Product Code Name
Mask, Oxygen, Non-Rebreathing
Public Device Record Key
ea434a56-bc62-4b51-9767-5b52dc3221e3
Public Version Date
August 14, 2020
Public Version Number
1
DI Record Publish Date
August 06, 2020
Package DI Number
10850014433922
Quantity per Package
50
Contains DI Package
00850014433925
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Case
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 6 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 1 |