Duns Number:690632047
Catalog Number
60146
Brand Name
Face Mask For Infant(20 pcs/box)
Version/Model Number
60146
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)
-
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
f15ec7d5-2178-4d06-810b-4f17ce7b0ee6
Public Version Date
January 29, 2019
Public Version Number
3
DI Record Publish Date
September 21, 2016
Package DI Number
14942962601464
Quantity per Package
20
Contains DI Package
04942962601467
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
BOX
Device Class | Device Class Description | No of Devices |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 4 |
2 | A medical device with a moderate to high risk that requires special controls. | 40 |