Duns Number:464246224
Device Description: KIRO Link is a software intended to store, convert formats, transfer and display the medic KIRO Link is a software intended to store, convert formats, transfer and display the medical data required for the integration and workflow management functionalities of compounding associated technologies. These technologies include customer site software (Computerized Physician Order Entry (CPOE), logistics, quality control, etc.), Pharmacy Compounding Devices (PCDs) and compounding assisting software. The software is intended to be used only by qualified pharmacy personnel.
Catalog Number
-
Brand Name
KIRO Link
Version/Model Number
1006
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
OUG
Product Code Name
Medical Device Data System
Public Device Record Key
f9aa368d-4ecb-4b08-8d7b-0c3f3ec04ace
Public Version Date
August 21, 2019
Public Version Number
2
DI Record Publish Date
November 07, 2018
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 |