DEVICE: Stat Profile (00385480485852)
Device Identifier (DI) Information
Stat Profile
pHOx Ultra/CCX
In Commercial Distribution
48585
NOVA BIOMEDICAL CORPORATION
pHOx Ultra/CCX
In Commercial Distribution
48585
NOVA BIOMEDICAL CORPORATION
Stat Profile pHOx Ultra/CCX Capillary Tube 230 uL with Na Heparin 250 per vial
Device Characteristics
| Labeling does not contain MRI Safety Information | |
| No | |
| No | |
| Yes | |
| Yes | |
| No | |
| No | |
| No | |
| No |
GMDN
[?]GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.
| GMDN Term Code | GMDN Term Name | GMDN Term Definition | GMDN Term Status [?] | Implantable? |
|---|---|---|---|---|
| 56668 | Metabolic profile clinical chemistry analyser IVD, portable, semi-automated |
A portable mains electricity (AC-powered) laboratory instrument, which may include internal rechargeable batteries, 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 in addition 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.
|
Obsolete | false |
FDA Product Code
[?]| Product Code | Product Code Name |
|---|---|
| JIX | CALIBRATOR, MULTI-ANALYTE MIXTURE |
| GJC | ASSAY, SULFHEMOGLOBIN |
| CFA | ELECTRODE, ION SPECIFIC, MAGNESIUM |
| CGZ | ELECTRODE, ION-SPECIFIC, CHLORIDE |
| JGS | ELECTRODE, ION SPECIFIC, SODIUM |
| JJB | AZO-DYES, COLORIMETRIC, BILIRUBIN & ITS CONJUGATES (URINARY, NON-QUANT.) |
| CEM | ELECTRODE, ION SPECIFIC, POTASSIUM |
| GKK | CYANOMETHEMOGLOBIN |
| GHS | ASSAY, CARBOXYHEMOGLOBIN |
| GLY | OXIMETER TO MEASURE HEMOGLOBIN |
| BXX | CALIBRATOR, PRESSURE, GAS |
| GGZ | OXYHEMOGLOBIN |
| CGA | GLUCOSE OXIDASE, GLUCOSE |
| NGD | TEST, LACTIC ACID, OVER THE COUNTER |
| CDS | ELECTRODE, ION SPECIFIC, UREA NITROGEN |
| CGL | ELECTRODE, ION BASED, ENZYMATIC, CREATININE |
| JFP | ELECTRODE, ION SPECIFIC, CALCIUM |
| CHL | ELECTRODE MEASUREMENT, BLOOD-GASES (PCO2, PO2) AND BLOOD PH |
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
6646bd96-aaab-4c24-ba7d-0d2cec80f55a
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:
00385489485853
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
+1(800)545-6682
info@novabio.com
info@novabio.com