DEVICE: StatSensor (00385480440523)

Device Identifier (DI) Information

StatSensor
1.0
In Commercial Distribution
44052
NOVA BIOMEDICAL CORPORATION
00385480440523
GS1

1
070617139 *Terms of Use
StatSensor Creatinine Meter with Battery and Quick Reference Guide
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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.
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FDA Product Code

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Product Code Product Code Name
CGL ELECTRODE, ION BASED, ENZYMATIC, CREATININE
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K070068 000
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Sterilization

No
No
Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

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Storage and Handling
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
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Clinically Relevant Size

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Size Type Text
No Device Sizes
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Device Record Status

48c6926e-4ba3-458a-be73-5c7202864577
July 06, 2018
3
September 20, 2016
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Alternative and Additional Identifiers Additional Identifiers

Package DI

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Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
10385480440520 1 00385480440523 In Commercial Distribution Carton
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Secondary DI

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Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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Unit of Use DI

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Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]
No
No
None
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Production Identifier(s) in UDI

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No
Yes
Yes
Yes
No CLOSE

Customer Contact

[?]
+1(800)545-6682
info@novabio.com
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