Duns Number:022721133
Device Description: Oxygen Mask (Adult) High Concentration non-rebreather, with safety vent 10’ (3.0 m) supply Oxygen Mask (Adult) High Concentration non-rebreather, with safety vent 10’ (3.0 m) supply tube, elastic strap fixation
Catalog Number
8130-10
Brand Name
n/a
Version/Model Number
8130-10
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
KGB
Product Code Name
MASK, OXYGEN, NON-REBREATHING
Public Device Record Key
1a2620ee-2128-4132-9182-6874784e7549
Public Version Date
May 23, 2018
Public Version Number
3
DI Record Publish Date
November 30, 2016
Package DI Number
10607411800921
Quantity per Package
50
Contains DI Package
00607411800924
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 |