Duns Number:206449154
Device Description: The Single-use Adult Medium Concentration Mask is used to provide respiratory therapy. It The Single-use Adult Medium Concentration Mask is used to provide respiratory therapy. It is achieved by connecting the device to an oxygen gas supply. The adult patient can inhale various concentration of oxygen through the mask.
Catalog Number
02RT1040-CS
Brand Name
O-Two
Version/Model Number
02RT1040
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
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
3e081b80-7546-4e9b-a5d0-d6a52cd70db1
Public Version Date
November 08, 2019
Public Version Number
1
DI Record Publish Date
October 31, 2019
Package DI Number
17540195070209
Quantity per Package
50
Contains DI Package
07540195070202
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 32 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 48 |
| U | Unclassified | 3 |