Duns Number:098240690
Device Description: "2.5 iChem Velocity Instrument Bring Up and Test; 800-7167 iChem VELOCITY Automated Urine "2.5 iChem Velocity Instrument Bring Up and Test; 800-7167 iChem VELOCITY Automated Urine Chemistry System w load/Unload (NA)""2.5 iChem Velocity Instrument Bring Up and Test; 800-7719 Stand-Alone Velocity (NA)"
Catalog Number
700-7176-001
Brand Name
iChem Velocity
Version/Model Number
Elite/Stand-Alone Velocity (NA)
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)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
KQO
Product Code Name
Automated Urinalysis System
Public Device Record Key
e22790d7-991d-42e3-97fa-227c6b9e28c0
Public Version Date
September 16, 2022
Public Version Number
3
DI Record Publish Date
September 07, 2016
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 | 20 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 6 |