Duns Number:008171162
Device Description: The S.G. Calibrator H is used to calibrate specific gravity on the AUTION HYBRID AU-4050, The S.G. Calibrator H is used to calibrate specific gravity on the AUTION HYBRID AU-4050, AUTION MAX AX-4030 and AUTION MAX AX-4280 Urine Analyzers. The calibration is scheduled to occur monthly or as needed.
Catalog Number
-
Brand Name
S.G. Calibrator H
Version/Model Number
100672
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)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K013783
Product Code
JMT
Product Code Name
Diazo (Colorimetric), Nitrite (Urinary, Non-Quant)
Public Device Record Key
fb1202f6-6985-4a4d-9eda-826a28ef36b4
Public Version Date
September 16, 2022
Public Version Number
4
DI Record Publish Date
April 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 |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 30 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 50 |