Duns Number:070617139
Device Description: Remanufactured Stat Profile Critical Care Xpress CO-Oximeter Analyzer
Catalog Number
37555
Brand Name
STAT PROFILE
Version/Model Number
CCX CO OX
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
K061830,K061830
Product Code
CDS
Product Code Name
ELECTRODE, ION SPECIFIC, UREA NITROGEN
Public Device Record Key
14775166-33d4-40d7-99c0-08c7ed43dae9
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
September 20, 2016
Package DI Number
10385480375556
Quantity per Package
1
Contains DI Package
00385480375559
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Box
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 165 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 210 |