DEVICE: STAT PROFILE (00385480359429)
Device Identifier (DI) Information
STAT PROFILE
CCX
In Commercial Distribution
35942
NOVA BIOMEDICAL CORPORATION
CCX
In Commercial Distribution
35942
NOVA BIOMEDICAL CORPORATION
Stat Profile Critical Care Express 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 |
|---|---|
| CGZ | ELECTRODE, ION-SPECIFIC, CHLORIDE |
| JPK | MIXTURE, HEMATOLOGY QUALITY CONTROL |
| CGL | ELECTRODE, ION BASED, ENZYMATIC, CREATININE |
| CHL | ELECTRODE MEASUREMENT, BLOOD-GASES (PCO2, PO2) AND BLOOD PH |
| CDS | ELECTRODE, ION SPECIFIC, UREA NITROGEN |
| GKR | SYSTEM, HEMOGLOBIN, AUTOMATED |
| JGS | ELECTRODE, ION SPECIFIC, SODIUM |
| JFP | ELECTRODE, ION SPECIFIC, CALCIUM |
| CGA | GLUCOSE OXIDASE, GLUCOSE |
| CFA | ELECTRODE, ION SPECIFIC, MAGNESIUM |
| CEM | ELECTRODE, ION SPECIFIC, POTASSIUM |
| JKS | Spectral absorb. Curve, oxyhemoglobin, carboxyhemoglobin, carbon-monoxide |
| GHS | ASSAY, CARBOXYHEMOGLOBIN |
| JIX | CALIBRATOR, MULTI-ANALYTE MIXTURE |
| JJS | CONTROLS FOR BLOOD-GASES, (ASSAYED AND UNASSAYED) |
| KHP | ACID, LACTIC, ENZYMATIC METHOD |
| JPI | DEVICE, HEMATOCRIT MEASURING |
FDA Premarket Submission
| FDA Premarket Submission Number [?] | Supplement Number [?] |
|---|---|
| K013729 | 000 |
Sterilization
Storage and Handling
[?]| Storage and Handling |
|---|
| Handling Environment Temperature: between 15 and 30 Degrees Celsius |
| Storage Environment Temperature: between 15 and 30 Degrees Celsius |
| Special Storage Condition, Specify: Without Condensation |
| Special Storage Condition, Specify: 0 ft to 9000 ft |
| Storage Environment Humidity: between 0 and 85 Percent (%) Relative Humidity |
Clinically Relevant Size
[?]| Size Type Text |
|---|
| No Device Sizes |
Device Record Status
02af949a-7b31-4cf5-a7a2-750f6a20e469
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 |
|---|---|---|---|---|---|
| 10385480359426 | 1 | 00385480359429 | 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