Duns Number:308667539
Device Description: S1837 Crea Calibration Solution 2, membrane bottle, 6x140 mL, for ABL8XX
Catalog Number
944-134
Brand Name
Crea Calibration Solution 2
Version/Model Number
944-134
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
Yes
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
68962502-9da2-4942-8144-f30be69b066d
Public Version Date
November 27, 2020
Public Version Number
3
DI Record Publish Date
September 01, 2016
Package DI Number
15700699441345
Quantity per Package
6
Contains DI Package
05700699441348
Package Discontinue Date
-
Package Status
In Commercial Distribution
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 |