Duns Number:041674552
Device Description: Venturi Mask Kit, Adult, All Diluters
Catalog Number
Not Applicable
Brand Name
MedSource Venturi Mask
Version/Model Number
MS-25200
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
3fe4caa5-75a2-40cd-9cf0-297d1ed09212
Public Version Date
June 07, 2021
Public Version Number
1
DI Record Publish Date
May 28, 2021
Package DI Number
00840155400344
Quantity per Package
50
Contains DI Package
00840155400337
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Case
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 498 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 90 |