Duns Number:464246224
Device Description: The KIRO SET is a sterile, single-use, disposable ancillary device used with the peristalt The KIRO SET is a sterile, single-use, disposable ancillary device used with the peristaltic pumps in the KIRO Oncology pharmacy compounding device for the transfer of fluids into sterile powder drug vials for reconstitution of intravenous drugs or into sterile medication containers for intravenous drug administration.
Catalog Number
-
Brand Name
KIRO Set
Version/Model Number
100801
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
Yes
Prescription Use (Rx)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K152441,K152441,K152441
Product Code
LHI
Product Code Name
Set, I.V. Fluid Transfer
Public Device Record Key
10260b7f-fcac-47b8-bbbb-715832102e40
Public Version Date
July 06, 2018
Public Version Number
5
DI Record Publish Date
November 11, 2016
Package DI Number
18437014572107
Quantity per Package
40
Contains DI Package
08437014572100
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Shipper Box
| 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 |