Duns Number:273647420
Catalog Number
-
Brand Name
Yumizen C1200 ALP
Version/Model Number
1300023830
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
Yes
Prescription Use (Rx)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K191245
Product Code
CJE
Product Code Name
Nitrophenylphosphate, Alkaline Phosphatase Or Isoenzymes
Public Device Record Key
cb0c0e63-230f-4459-b807-177219580962
Public Version Date
May 14, 2020
Public Version Number
1
DI Record Publish Date
May 06, 2020
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 |