Duns Number:368457563
Device Description: Dust Filter for Reusable Multi-Absorber
Catalog Number
1407-3201-000
Brand Name
Medisorb™
Version/Model Number
1407-3201-000
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
CBL
Product Code Name
Absorbent, Carbon-Dioxide
Public Device Record Key
c38dbed1-d1fa-4682-972a-f73ee74bf58b
Public Version Date
September 13, 2021
Public Version Number
1
DI Record Publish Date
September 03, 2021
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 | 13 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 600 |