Duns Number:825673239
Device Description: One Mask™ Oxygen MaskMask, Adapter, 79’’(200cm)Standard O2 Connector Oxygen Tubing w/Label One Mask™ Oxygen MaskMask, Adapter, 79’’(200cm)Standard O2 Connector Oxygen Tubing w/Label.
Catalog Number
OM004
Brand Name
One Mask™ Oxygen Mask
Version/Model Number
1
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
BYG
Product Code Name
Mask, Oxygen
Public Device Record Key
18bccfda-c0ad-420d-af86-44baa59675ac
Public Version Date
July 09, 2018
Public Version Number
1
DI Record Publish Date
June 07, 2018
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 89 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 411 |
| U | Unclassified | 1 |