Duns Number:041674552
Device Description: Non-Rebreather, Infant Under-Lip, U.Conn
Catalog Number
Not Applicable
Brand Name
MedSource Non-Rebreather Mask
Version/Model Number
MS-25055-U
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)
Yes
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
d71b0366-a11d-48a3-86d4-f1d00dd242f6
Public Version Date
June 03, 2021
Public Version Number
1
DI Record Publish Date
May 26, 2021
Package DI Number
00840155400030
Quantity per Package
50
Contains DI Package
00840155400023
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 | 498 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 90 |