DEVICE: STAT PROFILE (00385480374132)
Device Identifier (DI) Information
STAT PROFILE
CCX CO OX
In Commercial Distribution
37413
NOVA BIOMEDICAL CORPORATION
CCX CO OX
In Commercial Distribution
37413
NOVA BIOMEDICAL CORPORATION
Stat Profile Critical Care Express CO-Oximeter 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? |
|---|---|---|---|---|
| 56673 | Co-oximetry analyser IVD, point-of-care |
A mains electricity (AC-powered) instrument, which may include internal rechargeable batteries, intended to be used by health professionals at the point-of-care, and often in the laboratory, for the quantitative in vitro measurement of oxygen saturation, haemoglobin derivatives and other calculated haemoximetry parameters in a whole blood specimen. Measurements may include haemoglobin oxygen saturation (SpO2), arterial oxygen saturation (SaO2), blood oxygen content/capacity, and haemoglobin forms such as oxyhaemoglobin (O2Hb), deoxyhaemoglobin (HHb) or reduced haemoglobin (RHb), carboxy-haemoglobin (COHb), methaemoglobin (MetHb), sulfhaemoglobin (SHb), and total haemoglobin (totHb).
|
Active | false |
FDA Product Code
[?]| Product Code | Product Code Name |
|---|---|
| JJS | CONTROLS FOR BLOOD-GASES, (ASSAYED AND UNASSAYED) |
| JIX | CALIBRATOR, MULTI-ANALYTE MIXTURE |
| CGA | GLUCOSE OXIDASE, GLUCOSE |
| CIG | DIAZO COLORIMETRY, BILIRUBIN |
| CHL | ELECTRODE MEASUREMENT, BLOOD-GASES (PCO2, PO2) AND BLOOD PH |
| GKR | SYSTEM, HEMOGLOBIN, AUTOMATED |
| CDS | ELECTRODE, ION SPECIFIC, UREA NITROGEN |
| CGZ | ELECTRODE, ION-SPECIFIC, CHLORIDE |
| JPI | DEVICE, HEMATOCRIT MEASURING |
| CGL | ELECTRODE, ION BASED, ENZYMATIC, CREATININE |
| JJY | Multi-analyte controls, all kinds (assayed) |
| JPK | MIXTURE, HEMATOLOGY QUALITY CONTROL |
| CEM | ELECTRODE, ION SPECIFIC, POTASSIUM |
| JFP | ELECTRODE, ION SPECIFIC, CALCIUM |
| JKS | Spectral absorb. Curve, oxyhemoglobin, carboxyhemoglobin, carbon-monoxide |
| KHP | ACID, LACTIC, ENZYMATIC METHOD |
| CFA | ELECTRODE, ION SPECIFIC, MAGNESIUM |
| GHS | ASSAY, CARBOXYHEMOGLOBIN |
| JGS | ELECTRODE, ION SPECIFIC, SODIUM |
| JIT | CALIBRATOR, SECONDARY |
FDA Premarket Submission
| FDA Premarket Submission Number [?] | Supplement Number [?] |
|---|---|
| K061830 | 000 |
Sterilization
Storage and Handling
[?]| Storage and Handling |
|---|
| Special Storage Condition, Specify: 0 ft to 15000 ft |
| Special Storage Condition, Specify: Without Condensation |
| Storage Environment Temperature: between 15 and 30 Degrees Celsius |
| Handling Environment Temperature: between 15 and 30 Degrees Celsius |
| Storage Environment Humidity: between 0 and 85 Percent (%) Relative Humidity |
Clinically Relevant Size
[?]| Size Type Text |
|---|
| No Device Sizes |
Device Record Status
00aaa5ed-7c03-404c-838c-0e5c1382bbd1
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 |
|---|---|---|---|---|---|
| 10385480374139 | 1 | 00385480374132 | 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