Duns Number:438017964
Device Description: The Crono F is an ambulatory drug delivery pump designed to deliver subcutaneous and intra The Crono F is an ambulatory drug delivery pump designed to deliver subcutaneous and intravenous pulsatile infusion.
Catalog Number
-
Brand Name
Crono
Version/Model Number
F
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
MR Unsafe
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
K042085,K042085
Product Code
FRN
Product Code Name
Pump, Infusion
Public Device Record Key
c9e145a4-830e-46b3-a353-22f4ce0a63da
Public Version Date
June 17, 2022
Public Version Number
4
DI Record Publish Date
March 21, 2017
Package DI Number
08050616612076
Quantity per Package
1
Contains DI Package
08050616612069
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
box
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 8 |