Catalog Number
CP3720A
Brand Name
ChemoPlus
Version/Model Number
CP3720A
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)
-
Over the Counter (OTC)
Yes
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
e6545170-b49d-4429-a4d8-ec904469c4cd
Public Version Date
November 08, 2021
Public Version Number
8
DI Record Publish Date
September 24, 2016
Package DI Number
20884527006394
Quantity per Package
12000
Contains DI Package
10884527006397
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 | 672 |
2 | A medical device with a moderate to high risk that requires special controls. | 1692 |
U | Unclassified | 17 |