Duns Number:029062325
Device Description: EXP-PAK Cell Expansion Container 500 mL Capacity
Catalog Number
EXP-500
Brand Name
EXP-PAK
Version/Model Number
EXP-500
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
-
Product Code
KJF
Product Code Name
System, Suspension, Cell Culture
Public Device Record Key
a39addc5-67d2-4d7d-a982-72065dec41f1
Public Version Date
June 17, 2022
Public Version Number
2
DI Record Publish Date
August 23, 2021
Package DI Number
00817827027543
Quantity per Package
12
Contains DI Package
00817827027048
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 5 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 75 |
| U | Unclassified | 7 |