Duns Number:010712461
Device Description: Adult High Concentration Procedural Oxygen Mask
Catalog Number
301-0319LT
Brand Name
Curaplex
Version/Model Number
301-0319LT
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
December 18, 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"
Yes
For Single-Use
Yes
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
BYG
Product Code Name
MASK, OXYGEN
Public Device Record Key
002be4d1-23d8-47b8-a4d9-2a1badcfc987
Public Version Date
January 14, 2021
Public Version Number
2
DI Record Publish Date
July 01, 2019
Package DI Number
00818834028059
Quantity per Package
30
Contains DI Package
00818834028042
Package Discontinue Date
December 18, 2020
Package Status
Not in Commercial Distribution
Package Type
BX
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 92 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 92 |