DEVICE: i-STAT (00054749003860)

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Device Identifier (DI) Information

i-STAT
04P75-40
04P75-40
ABBOTT POINT OF CARE INC.
00054749003860
GS1
1
i-STAT 1 Analyzer, Immuno Ready
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
No
No
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
CGA GLUCOSE OXIDASE, GLUCOSE
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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
Handling Environment Humidity: less than 90 Percent (%) Relative Humidity
Handling Environment Temperature: between -10 and 46 Degrees Celsius
Handling Environment Atmospheric Pressure: between 40000 and 113324 KiloPascal
Storage Environment Humidity: less than 90 Percent (%) Relative Humidity
Storage Environment Atmospheric Pressure: between 40000 and 113324 KiloPascal
Storage Environment Temperature: between 16 and 30 Degrees Celsius
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Clinically Relevant Size

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Size Type Text
No Device Sizes
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Device Status

In Commercial Distribution
September 09, 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
No Package DIs found
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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)

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No
No
None
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Production Identifier(s) in UDI

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Yes
Yes
No
No
No CLOSE

Customer Contact

[?]
+1(800)366-8020
techsvc@apoc.abbott.com
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