Duns Number:106908437
Device Description: REPLACEMENT VALVE FOR MICROMASK, 1-EACH
Catalog Number
-
Brand Name
MICROTEK
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"
-
For Single-Use
Yes
Prescription Use (Rx)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K950769,K950769
Product Code
CBP
Product Code Name
Valve, non-rebreathing
Public Device Record Key
b9025624-90ac-4b17-951b-f6a574672915
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
March 31, 2017
Package DI Number
50748426075411
Quantity per Package
20
Contains DI Package
00748426175413
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 | 1 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 919 |