Duns Number:202659140
Device Description: AMSCO 1215 Cart and Utensil Washer/Disinfector, 380-400-415V, 50hz, Steam Heated has a sma AMSCO 1215 Cart and Utensil Washer/Disinfector, 380-400-415V, 50hz, Steam Heated has a small footprint that maximizes experiences by significantly reducing manual cleaning of case carts and containers.
Catalog Number
FW12103
Brand Name
AMSCO
Version/Model Number
1215
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
4a1dba3f-5e25-4a59-927c-62cdeb404abb
Public Version Date
August 23, 2021
Public Version Number
1
DI Record Publish Date
August 13, 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 | 58 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 262 |