Duns Number:106712748
Catalog Number
21-2120-0102-51
Brand Name
CADD-Solis
Version/Model Number
2120
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)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K111275
Product Code
FRN
Product Code Name
Pump, infusion
Public Device Record Key
8cb11118-5cc6-4ca0-a56a-0523c4f37029
Public Version Date
July 04, 2022
Public Version Number
6
DI Record Publish Date
March 23, 2017
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 | 3 |
2 | A medical device with a moderate to high risk that requires special controls. | 686 |
3 | A medical device with high risk that requires premarket approval | 2 |
U | Unclassified | 1 |