Duns Number:438017964
Device Description: The CRONO Super PID is an ambulatory syringe infusion pump intended for the controlled, su The CRONO Super PID is an ambulatory syringe infusion pump intended for the controlled, subcutaneous administration of liquids.
Catalog Number
-
Brand Name
Crono
Version/Model Number
Super PID
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
K052217,K052217
Product Code
FRN
Product Code Name
Pump, Infusion
Public Device Record Key
ad2ff016-3c8c-4f13-9cca-7eb1fbbba362
Public Version Date
June 17, 2022
Public Version Number
4
DI Record Publish Date
March 21, 2017
Package DI Number
08050616612038
Quantity per Package
1
Contains DI Package
08050616612021
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 |