Duns Number:002397347
Device Description: EVA Single-Chamber Final Containers 4000 mL
Catalog Number
2112533
Brand Name
APEX™
Version/Model Number
2112533
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"
Yes
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
KPE
Product Code Name
CONTAINER, I.V.
Public Device Record Key
5126a5f2-641d-41b7-a7d3-541ed1c60bbf
Public Version Date
March 27, 2020
Public Version Number
4
DI Record Publish Date
September 23, 2016
Package DI Number
04046964539251
Quantity per Package
5
Contains DI Package
04046964539244
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Carton
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 16 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 277 |
| U | Unclassified | 2 |