Duns Number:080935429
Device Description: Red IVA Seals
Catalog Number
CP3011R
Brand Name
ChemoPlus
Version/Model Number
CP3011R
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)
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
4b5db37a-48b1-4956-83b6-184676ac56a8
Public Version Date
November 08, 2021
Public Version Number
8
DI Record Publish Date
September 24, 2016
Package DI Number
20884527006233
Quantity per Package
20000
Contains DI Package
10884527006236
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 |