AccessGUDID - DEVICE: Stat Profile (00385480485876)

GUDID

Device Identifier (DI) Information

Brand Name: Stat Profile
Version or Model: Prime/pHOx Ultra/CCX
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 48587
Company Name: NOVA BIOMEDICAL CORPORATION

Primary DI Number: 00385480485876
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 10
Labeler D-U-N-S® Number*: 070617139 *Terms of Use

Device Description: Prime/StatProfile pHOx Ultra/CCX Magnets for Capillary Tubes 10 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
JJB	AZO-DYES, COLORIMETRIC, BILIRUBIN & ITS CONJUGATES (URINARY, NON-QUANT.)
GLY	OXIMETER TO MEASURE HEMOGLOBIN
CDS	ELECTRODE, ION SPECIFIC, UREA NITROGEN
CGL	ELECTRODE, ION BASED, ENZYMATIC, CREATININE
JFP	ELECTRODE, ION SPECIFIC, CALCIUM
GHS	ASSAY, CARBOXYHEMOGLOBIN
CHL	ELECTRODE MEASUREMENT, BLOOD-GASES (PCO2, PO2) AND BLOOD PH
GKK	CYANOMETHEMOGLOBIN
CGA	GLUCOSE OXIDASE, GLUCOSE
CFA	ELECTRODE, ION SPECIFIC, MAGNESIUM
NGD	TEST, LACTIC ACID, OVER THE COUNTER
CGZ	ELECTRODE, ION-SPECIFIC, CHLORIDE
JGS	ELECTRODE, ION SPECIFIC, SODIUM
BXX	CALIBRATOR, PRESSURE, GAS
GGZ	OXYHEMOGLOBIN
GJC	ASSAY, SULFHEMOGLOBIN
JIX	CALIBRATOR, MULTI-ANALYTE MIXTURE
CEM	ELECTRODE, ION SPECIFIC, POTASSIUM

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: 7ace2a9b-a4cf-4225-b325-dca5f7b46eb1
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: September 20, 2016