Duns Number:859679045
Device Description: Suction-Drain System to continuously collect body fluids and dispose of them via sanitary Suction-Drain System to continuously collect body fluids and dispose of them via sanitary sewer. One unit.
Catalog Number
DM60002A
Brand Name
Environ-mate
Version/Model Number
DM6000-2A
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
July 31, 2025
Issuing Agency
In HIBCC
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
-
Prescription Use (Rx)
-
Over the Counter (OTC)
Yes
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
KDQ
Product Code Name
Bottle, Collection, Vacuum
Public Device Record Key
5acf929a-781b-47d1-ac1e-7f92d7d9e719
Public Version Date
August 15, 2022
Public Version Number
1
DI Record Publish Date
August 05, 2022
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 | 1 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 6 |