Duns Number:354019424
Device Description: Contains ten ampoules of Maintenance Concentrate, one vial of Anti-Foam and one package of Contains ten ampoules of Maintenance Concentrate, one vial of Anti-Foam and one package of CheckCAP for use with Phadia instruments.
Catalog Number
10-9476-01
Brand Name
Maintenance Solution Kit
Version/Model Number
10-9476-01
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)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
JJE
Product Code Name
ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE
Public Device Record Key
bba7df94-be7c-4d1b-aaa6-249febd8cde9
Public Version Date
April 08, 2020
Public Version Number
1
DI Record Publish Date
March 31, 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 | 225 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 518 |