Duns Number:022721133
Device Description: Oxygen Mask (Adult) Medium Concentration, 7’ (2.1 m) supply tube, elastic strap fixation
Catalog Number
SO-65-0
Brand Name
n/a
Version/Model Number
SO-65-0
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
-
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
54c0ad60-5521-4431-8a0e-453c5bb1f320
Public Version Date
May 23, 2018
Public Version Number
3
DI Record Publish Date
November 30, 2016
Package DI Number
10607411900645
Quantity per Package
50
Contains DI Package
00607411900648
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 | 865 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 1134 |