Duns Number:438017964
Device Description: The CRONO S-PID 50 is an ambulatory syringe infusion pump intended exclusively for the con The CRONO S-PID 50 is an ambulatory syringe infusion pump intended exclusively for the controlled subcutaneous administration of immunoglobulin.
Catalog Number
-
Brand Name
Crono
Version/Model Number
S-PID 50
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
K091042,K091042
Product Code
FRN
Product Code Name
Pump, Infusion
Public Device Record Key
fc7d14c9-999a-4a16-9522-e02ed89d5821
Public Version Date
June 17, 2022
Public Version Number
4
DI Record Publish Date
October 06, 2016
Package DI Number
08050616612014
Quantity per Package
1
Contains DI Package
08050616612007
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 |