Duns Number:273647420
Device Description: AC 220V Class2 Laser Product + AC100VThis device is a combination between the Yumizen C120 AC 220V Class2 Laser Product + AC100VThis device is a combination between the Yumizen C1200 (CA-20151BM6010C) and the autoloader RAmini (CA-21391RAMINI).
Catalog Number
3200675839/3200685493
Brand Name
Yumizen C1200 AL
Version/Model Number
CA-20151BM6010C/CA-21391RAMINI
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)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K183375
Product Code
JJE
Product Code Name
Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
Public Device Record Key
705344e2-edcd-4f32-9dfb-6e09892d2ff9
Public Version Date
September 16, 2022
Public Version Number
2
DI Record Publish Date
February 16, 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 | 104 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 100 |