Duns Number:308667539
Device Description: Sensor cassette SC90 300BG, LYT, MET, OXI + QC for ABL90. 300 tests, Blood gas. Electrolyt Sensor cassette SC90 300BG, LYT, MET, OXI + QC for ABL90. 300 tests, Blood gas. Electrolytes, Metabolites, CO-OX, Including Auto QC
Catalog Number
946-005
Brand Name
ABL90 Sensor Cassette pack
Version/Model Number
946-005
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
CEM
Product Code Name
ELECTRODE, ION SPECIFIC, POTASSIUM
Public Device Record Key
e46ea0e9-650b-4080-8a5d-a1377f343985
Public Version Date
November 27, 2020
Public Version Number
3
DI Record Publish Date
September 01, 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 | 124 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 66 |