Duns Number:070617139
Device Description: Stat Profile pHOx Ultra Co-Oximeter S-Line Probe Assembly
Catalog Number
48562
Brand Name
STAT PROFILE
Version/Model Number
PHOX ULTRA
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
K110648,K110648
Product Code
BXX
Product Code Name
CALIBRATOR, PRESSURE, GAS
Public Device Record Key
9490ff6e-475c-4a16-997d-d031b80c977d
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
September 20, 2016
Package DI Number
10385480485620
Quantity per Package
1
Contains DI Package
00385480485623
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
carton
| 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 |