Duns Number:079226220
Device Description: CELL-DYN 1800 System DETERGENT
Catalog Number
9932602
Brand Name
CELL-DYN
Version/Model Number
99326-02
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
December 31, 2018
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
JCB
Product Code Name
DETERGENT
Public Device Record Key
2273410d-12b0-40b9-a3e2-721022c00ff9
Public Version Date
June 14, 2019
Public Version Number
4
DI Record Publish Date
September 09, 2016
Package DI Number
00380740020996
Quantity per Package
4
Contains DI Package
00380740135737
Package Discontinue Date
December 31, 2018
Package Status
Not in Commercial Distribution
Package Type
Case
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 259 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 245 |
| U | Unclassified | 5 |