Duns Number:154454730
Catalog Number
MC-650
Brand Name
HME/BFE/VFE Filter
Version/Model Number
MC-650
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)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
BYD
Product Code Name
Condenser, Heat And Moisture (Artificial Nose)
Public Device Record Key
b50375df-cb4c-4555-94cc-1196039e6173
Public Version Date
December 22, 2021
Public Version Number
3
DI Record Publish Date
September 11, 2017
Package DI Number
10858409005143
Quantity per Package
50
Contains DI Package
00858409005146
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 | 53 |
2 | A medical device with a moderate to high risk that requires special controls. | 5 |