DEVICE: StatSensor (00385480440523)
Device Identifier (DI) Information
StatSensor
1.0
In Commercial Distribution
44052
NOVA BIOMEDICAL CORPORATION
1.0
In Commercial Distribution
44052
NOVA BIOMEDICAL CORPORATION
StatSensor Creatinine Meter with Battery and Quick Reference Guide
Device Characteristics
Labeling does not contain MRI Safety Information | |
No | |
No | |
No | |
Yes | |
No | |
No | |
No | |
No |
GMDN
[?]GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.
GMDN Preferred Term Name | GMDN Definition |
---|---|
Metabolic profile clinical chemistry analyser IVD, portable, semi-automated | A portable mains electricity (AC-powered) laboratory instrument, typically with rechargeable batteries for power at point-of-care in acute care settings, intended to be used for the qualitative and/or quantitative in vitro measurement of multiple clinical chemistry analytes to generate a metabolic profile. Analytes may include pH, blood gas parameters (e.g., pO2, pCO2), electrolytes [e.g., sodium (Na2+), potassium (K+), chloride (Cl-)], glucose, urea, creatinine and sometimes haemoximetry parameters [e.g., carboxy-haemoglobin (COHb), methaemoglobin (MetHb), total haemoglobin (totHb), hematrocrit (Hct)]. It operates with reduced technician involvement and automation of some procedural steps. |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
CGL | ELECTRODE, ION BASED, ENZYMATIC, CREATININE |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
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K070068 | 000 |
Sterilization
Storage and Handling
[?]Storage and Handling |
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Special Storage Condition, Specify: Without Condensation |
Storage Environment Temperature: between 15 and 40 Degrees Celsius |
Handling Environment Temperature: between 15 and 40 Degrees Celsius |
Special Storage Condition, Specify: 0 ft to 15000 ft |
Storage Environment Humidity: between 0 and 90 Percent (%) Relative Humidity |
Clinically Relevant Size
[?]Size Type Text |
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No Device Sizes |
Device Record Status
48c6926e-4ba3-458a-be73-5c7202864577
July 06, 2018
3
September 20, 2016
July 06, 2018
3
September 20, 2016
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
---|---|---|---|---|---|
10385480440520 | 1 | 00385480440523 | In Commercial Distribution | Carton |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
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No Secondary DIs found |
Unit of Use DI
[?]
Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
+1(800)545-6682
info@novabio.com
info@novabio.com