Duns Number:246848147
Device Description: OXYMULTI PLUS MASK W ADAPTER & 7ft TUBING
Catalog Number
OPHH-1025-8
Brand Name
OxyMulti-Mask™
Version/Model Number
OPHH-1025-8
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)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K760489,K760489
Product Code
CAF
Product Code Name
NEBULIZER (DIRECT PATIENT INTERFACE)
Public Device Record Key
10d0d69f-f11f-4d10-b389-1dc1ba12b9e3
Public Version Date
July 06, 2018
Public Version Number
4
DI Record Publish Date
September 01, 2016
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 | 91 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 18 |
| 3 | A medical device with high risk that requires premarket approval | 2 |