DEVICE: Stat Profile (00385480485876)
Device Identifier (DI) Information
Stat Profile
Prime/pHOx Ultra/CCX
In Commercial Distribution
48587
NOVA BIOMEDICAL CORPORATION
Prime/pHOx Ultra/CCX
In Commercial Distribution
48587
NOVA BIOMEDICAL CORPORATION
Prime/StatProfile pHOx Ultra/CCX Magnets for Capillary Tubes 10 per vial
Device Characteristics
Labeling does not contain MRI Safety Information | |
No | |
No | |
Yes | |
Yes | |
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 |
---|---|
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 |
Sterilization
Storage and Handling
[?]Storage and Handling |
---|
No storage/handling found |
Clinically Relevant Size
[?]Size Type Text |
---|
No Device Sizes |
Device Record Status
7ace2a9b-a4cf-4225-b325-dca5f7b46eb1
July 06, 2018
3
September 20, 2016
July 06, 2018
3
September 20, 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 |
---|---|---|---|---|---|
No Package DIs found |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
---|---|
No Secondary DIs found |
Unit of Use DI
[?]
Unit of Use DI Number:
00385489485877
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
+1(800)545-6682
info@novabio.com
info@novabio.com