Duns Number:064608573
Device Description: Blank Sensor used For GLU or LAC on Siemens Healthcare Diagnostics RAPIDLab® Series system Blank Sensor used For GLU or LAC on Siemens Healthcare Diagnostics RAPIDLab® Series systems.
Catalog Number
673701000
Brand Name
TB4 Glu/Lac Test/Blank Sensor
Version/Model Number
10326708
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)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K031560
Product Code
CEM
Product Code Name
ELECTRODE, ION SPECIFIC, POTASSIUM
Public Device Record Key
8a7251e1-1450-4e55-a8e6-e7f70a4080ea
Public Version Date
November 19, 2021
Public Version Number
6
DI Record Publish Date
September 24, 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 | 363 |
2 | A medical device with a moderate to high risk that requires special controls. | 829 |
3 | A medical device with high risk that requires premarket approval | 57 |
U | Unclassified | 7 |