Duns Number:464246224
Device Description: KIRO Fill is an automated pharmacy compounding device (PCD) for the preparation of non-haz KIRO Fill is an automated pharmacy compounding device (PCD) for the preparation of non-hazardous Compounded Sterile Preparations (CSPs). The device is intended to be used only by qualified pharmacy personnel.
Catalog Number
-
Brand Name
KIRO Fill US
Version/Model Number
1002US
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)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
NEP
Product Code Name
System/Device, Pharmacy Compounding
Public Device Record Key
de611c11-5dbf-4cd1-9429-6e9ac6deccb8
Public Version Date
December 24, 2019
Public Version Number
1
DI Record Publish Date
December 16, 2019
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 | 1 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 2 |