Duns Number:556957871
Device Description: Weekly use of liquid controls are important for calibration verification of the Oxicom. Li Weekly use of liquid controls are important for calibration verification of the Oxicom. Liquid controls are available in three levels – for monitoring performance of significant points within the clinical range.
Catalog Number
0034091.000
Brand Name
CONTROL LIQUID, OXICOM - Medium vial
Version/Model Number
CONTROL LIQUID, OXICOM - Medium vial
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In HIBCC
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
DQA
Product Code Name
Oximeter
Public Device Record Key
ac6e0078-f1b0-478c-8f74-1c13580c1bc1
Public Version Date
March 21, 2019
Public Version Number
3
DI Record Publish Date
February 12, 2017
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 |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 53 |