AccessGUDID - DEVICE: i-STAT (00054749003846)

GUDID

Device Identifier (DI) Information

Brand Name: i-STAT
Version or Model: 03P75-63
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 03P75-63
Company Name: ABBOTT POINT OF CARE INC.

Primary DI Number: 00054749003846
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 079226216 *Terms of Use

Device Description: i-Stat 1 Wireless Analyzer

Device Characteristics

What MRI safety information does the labeling contain?	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):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	No
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

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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.

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

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Product Code	Product Code Name
CGA	GLUCOSE OXIDASE, GLUCOSE

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: Yes CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

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Storage and Handling
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

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Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 9a15346c-29fe-4e76-9258-bf922e8148e5
Public Version Date: March 29, 2018
Public Version Number: 2
DI Record Publish Date: September 09, 2016