DEVICE: i-STAT (00054749003846)
Device Identifier (DI) Information
i-STAT
03P75-63
In Commercial Distribution
03P75-63
ABBOTT POINT OF CARE INC.
03P75-63
In Commercial Distribution
03P75-63
ABBOTT POINT OF CARE INC.
i-Stat 1 Wireless Analyzer
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. |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
CGA | GLUCOSE OXIDASE, GLUCOSE |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
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Premarket Submission Number Not Available/Not Released |
Sterilization
Storage and Handling
[?]Storage and Handling |
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Storage Environment Humidity: less than 90 Percent (%) Relative Humidity |
Handling Environment Atmospheric Pressure: between 40000 and 113324 KiloPascal |
Handling Environment Humidity: less than 90 Percent (%) Relative Humidity |
Storage Environment Atmospheric Pressure: between 40000 and 113324 KiloPascal |
Handling Environment Temperature: between -10 and 46 Degrees Celsius |
Storage Environment Temperature: between 16 and 30 Degrees Celsius |
Clinically Relevant Size
[?]Size Type Text |
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No Device Sizes |
Device Record Status
9a15346c-29fe-4e76-9258-bf922e8148e5
March 29, 2018
2
September 09, 2016
March 29, 2018
2
September 09, 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 |
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No Package DIs found |
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)366-8020
techsvc@apoc.abbott.com
techsvc@apoc.abbott.com