Duns Number:200103823
Device Description: Rescuer O-Mask Oxygen Mask with Universal Tubing (Child)
Catalog Number
6210-U
Brand Name
Rescuer O-Mask Oxygen Mask with Universal Tubing
Version/Model Number
6210-U
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In HIBCC
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
KGB
Product Code Name
Mask, Oxygen, Non-Rebreathing
Public Device Record Key
e31022a4-09b2-4afe-8dd9-d86aed543b30
Public Version Date
April 09, 2021
Public Version Number
1
DI Record Publish Date
April 01, 2021
Package DI Number
B0026210U7
Quantity per Package
50
Contains DI Package
B0026210U0
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Carton
Device Class | Device Class Description | No of Devices |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 15 |
2 | A medical device with a moderate to high risk that requires special controls. | 32 |