Duns Number:002397347
Device Description: SCB 500ML EVA MIXING CONT. SINGLE PACK
Catalog Number
2112610
Brand Name
PINNACLE®
Version/Model Number
2112610
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
e73deb4c-8bf7-4a1e-b752-5ba302d15855
Public Version Date
October 24, 2022
Public Version Number
1
DI Record Publish Date
October 16, 2022
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
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 |