Duns Number:202659140
Device Description: The AMSCO 3052 Single-Chamber Washer Disinfector is designed for use in the cleaning and i The AMSCO 3052 Single-Chamber Washer Disinfector is designed for use in the cleaning and intermediate-level disinfection of soiled reusable utensils, trays, bedpans and urinals. It can also be used for rubber and plastic goods, simple hard-surfaced rigid surgical instruments (such as forceps and clamps) and other similar and related articles found in healthcare facilities.
Catalog Number
FH16
Brand Name
AMSCO
Version/Model Number
3052
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
-
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
MEC
Product Code Name
Disinfector, medical devices
Public Device Record Key
5337d4ac-111e-4674-9e13-8e6a82e16e5f
Public Version Date
January 28, 2021
Public Version Number
4
DI Record Publish Date
September 13, 2016
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 | 58 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 262 |