Duns Number:273647420
Device Description: Yumizen C1200 Creatinine PAP1300023844 : R1 ( 4x46 mL ; R2 3x34 mL) 1300023843 : R1 ( 6x35 Yumizen C1200 Creatinine PAP1300023844 : R1 ( 4x46 mL ; R2 3x34 mL) 1300023843 : R1 ( 6x35 mL ; R2 6x19 mL)
Catalog Number
-
Brand Name
Yumizen C1200 Creatinine PAP
Version/Model Number
1300023844
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
K193649
Product Code
JFY
Product Code Name
Enzymatic Method, Creatinine
Public Device Record Key
4a52aa4c-cde4-4545-acf4-9f80101270c3
Public Version Date
June 25, 2021
Public Version Number
1
DI Record Publish Date
June 17, 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 |