DEVICE: STAT PROFILE (00385480420181)
Device Identifier (DI) Information
STAT PROFILE
PHOX ULTRA
In Commercial Distribution
42018
NOVA BIOMEDICAL CORPORATION
PHOX ULTRA
In Commercial Distribution
42018
NOVA BIOMEDICAL CORPORATION
Remanufactured Stat Profile pHOx Ultra Analyzer
Device Characteristics
| Labeling does not contain MRI Safety Information | |
| No | |
| No | |
| No | |
| 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 |
|---|---|
| GHS | ASSAY, CARBOXYHEMOGLOBIN |
| CGL | ELECTRODE, ION BASED, ENZYMATIC, CREATININE |
| JIX | CALIBRATOR, MULTI-ANALYTE MIXTURE |
| JFP | ELECTRODE, ION SPECIFIC, CALCIUM |
| NGD | TEST, LACTIC ACID, OVER THE COUNTER |
| GJC | ASSAY, SULFHEMOGLOBIN |
| GLY | OXIMETER TO MEASURE HEMOGLOBIN |
| CFA | ELECTRODE, ION SPECIFIC, MAGNESIUM |
| CGA | GLUCOSE OXIDASE, GLUCOSE |
| JGS | ELECTRODE, ION SPECIFIC, SODIUM |
| GGZ | OXYHEMOGLOBIN |
| CDS | ELECTRODE, ION SPECIFIC, UREA NITROGEN |
| GKK | CYANOMETHEMOGLOBIN |
| CHL | ELECTRODE MEASUREMENT, BLOOD-GASES (PCO2, PO2) AND BLOOD PH |
| JJB | AZO-DYES, COLORIMETRIC, BILIRUBIN & ITS CONJUGATES (URINARY, NON-QUANT.) |
| BXX | CALIBRATOR, PRESSURE, GAS |
| CGZ | ELECTRODE, ION-SPECIFIC, CHLORIDE |
| CEM | ELECTRODE, ION SPECIFIC, POTASSIUM |
FDA Premarket Submission
| FDA Premarket Submission Number [?] | Supplement Number [?] |
|---|---|
| K110648 | 000 |
Sterilization
Storage and Handling
[?]| Storage and Handling |
|---|
| Special Storage Condition, Specify: Without Condensation |
| Storage Environment Temperature: between 15 and 30 Degrees Celsius |
| Special Storage Condition, Specify: 0 ft to 15000 ft |
| Handling Environment Temperature: between 15 and 30 Degrees Celsius |
| Storage Environment Humidity: between 20 and 85 Percent (%) Relative Humidity |
Clinically Relevant Size
[?]| Size Type Text |
|---|
| No Device Sizes |
Device Record Status
aae0a284-ae8d-4dd3-96af-25ea9b05aaa8
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 |
|---|---|---|---|---|---|
| 10385480420188 | 1 | 00385480420181 | In Commercial Distribution | Box |
Secondary DI
[?]| Issuing Agency [?] | Secondary DI Number |
|---|---|
| No Secondary DIs found | |
Unit of Use DI
[?]
Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
+1(800)545-6682
info@novabio.com
info@novabio.com