Duns Number:625272232
Device Description: 120ml EVO cell culture bag, with female luers Additional, female to male tube accessory se 120ml EVO cell culture bag, with female luers Additional, female to male tube accessory set 12cm in length
Catalog Number
-
Brand Name
Evolve
Version/Model Number
EV120 + F-M12
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)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
KJA
Product Code Name
Flask, Tissue Culture
Public Device Record Key
624f93d0-d04f-4aba-9bc8-d1845bc5d1bc
Public Version Date
June 17, 2022
Public Version Number
3
DI Record Publish Date
September 23, 2016
Package DI Number
20816203020097
Quantity per Package
20
Contains DI Package
10816203020090
Package Discontinue Date
-
Package Status
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 | 22 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 18 |
| U | Unclassified | 44 |