AccessGUDID - DEVICE: Stat Profile (00385480485890)

GUDID

Device Identifier (DI) Information

Brand Name: Stat Profile
Version or Model: pHOx Ultra/CCX
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 48589
Company Name: NOVA BIOMEDICAL CORPORATION

Primary DI Number: 00385480485890
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 250
Labeler D-U-N-S® Number*: 070617139 *Terms of Use

Device Description: Stat Profile pHOx Ultra/CCX Capillary Tube 115 uL with Na Heparin 250 per Vial

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:	Yes
Prescription Use (Rx):	Yes
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
CGZ	ELECTRODE, ION-SPECIFIC, CHLORIDE
NGD	TEST, LACTIC ACID, OVER THE COUNTER
CGL	ELECTRODE, ION BASED, ENZYMATIC, CREATININE
CFA	ELECTRODE, ION SPECIFIC, MAGNESIUM
JFP	ELECTRODE, ION SPECIFIC, CALCIUM
GHS	ASSAY, CARBOXYHEMOGLOBIN
GLY	OXIMETER TO MEASURE HEMOGLOBIN
BXX	CALIBRATOR, PRESSURE, GAS
JJB	AZO-DYES, COLORIMETRIC, BILIRUBIN & ITS CONJUGATES (URINARY, NON-QUANT.)
CHL	ELECTRODE MEASUREMENT, BLOOD-GASES (PCO2, PO2) AND BLOOD PH
JIX	CALIBRATOR, MULTI-ANALYTE MIXTURE
JGS	ELECTRODE, ION SPECIFIC, SODIUM
CEM	ELECTRODE, ION SPECIFIC, POTASSIUM
CDS	ELECTRODE, ION SPECIFIC, UREA NITROGEN
GKK	CYANOMETHEMOGLOBIN
GJC	ASSAY, SULFHEMOGLOBIN
GGZ	OXYHEMOGLOBIN

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K110648	000

Device Exempt from Premarket Submission: No 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
No storage/handling found

Clinically Relevant Size

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Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 86a53277-7dd0-41f9-b5b9-455782d0cb98
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: September 20, 2016