Duns Number:098240690
Device Description: "iQ200 Sprint 2008 Tested; 800-3053 iQ®200 Sprint Pro (NA)""iQ200 Sprint 2008 Tested; 800- "iQ200 Sprint 2008 Tested; 800-3053 iQ®200 Sprint Pro (NA)""iQ200 Sprint 2008 Tested; 800-3081 iQ200 SPRINT w load/unload (NA);""iQ200 Sprint 2008 Tested; 800-3082 iQ200 SPRINT Pro w load/unload (NA); 800-3080 IRICELL 3000 PRO w load/unload; 800-3048 IRICELL 3000 Pro (NA)""iQ200 Sprint 2008 Tested; 800-3933 iQ®200 Sprint Plus US (2008 Version) (NA); 800-7713 IRICELL 3000 Plus (NA);800-3079 IRICELL 3000 Plus w/ Load Unload (NA)"
Catalog Number
700-3325
Brand Name
iQ200
Version/Model Number
Sprint Pro (NA)/SPRINT w load/unload (NA)/SPRINT Pro w load/unload (NA)/Sprint P
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
K022774
Product Code
KQO
Product Code Name
Automated Urinalysis System
Public Device Record Key
fbfa60cb-c45f-40c9-82d2-b9c58d4f25af
Public Version Date
September 16, 2022
Public Version Number
4
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 |