Duns Number:064608573
Device Description: NA+/K+/CA++/CL- Electrode fill solution. In vitro diagnostics material for use with RAPIDL NA+/K+/CA++/CL- Electrode fill solution. In vitro diagnostics material for use with RAPIDLab® 1200 electrodes.
Catalog Number
10376882
Brand Name
RAPIDLab® 1200 Na+/K+/Ca++/CL- Electrode Fill
Version/Model Number
10376882
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,K031560
Product Code
CEM
Product Code Name
ELECTRODE, ION SPECIFIC, POTASSIUM
Public Device Record Key
3c529a65-aaad-4d7e-9b79-a5b949089507
Public Version Date
November 19, 2021
Public Version Number
5
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 |