DEVICE: STAT PROFILE (00385480367943)
Device Identifier (DI) Information
STAT PROFILE
CCX
In Commercial Distribution
36794
NOVA BIOMEDICAL CORPORATION
CCX
In Commercial Distribution
36794
NOVA BIOMEDICAL CORPORATION
STAT PROFILE CRITICAL CARE XPRESS CONTROL FLUSH FIXTURE
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 |
|---|---|
| JPI | DEVICE, HEMATOCRIT MEASURING |
| KHP | ACID, LACTIC, ENZYMATIC METHOD |
| CGA | GLUCOSE OXIDASE, GLUCOSE |
| CHL | ELECTRODE MEASUREMENT, BLOOD-GASES (PCO2, PO2) AND BLOOD PH |
| JGS | ELECTRODE, ION SPECIFIC, SODIUM |
| CDS | ELECTRODE, ION SPECIFIC, UREA NITROGEN |
| CFA | ELECTRODE, ION SPECIFIC, MAGNESIUM |
| CEM | ELECTRODE, ION SPECIFIC, POTASSIUM |
| JJS | CONTROLS FOR BLOOD-GASES, (ASSAYED AND UNASSAYED) |
| JFP | ELECTRODE, ION SPECIFIC, CALCIUM |
| JPK | MIXTURE, HEMATOLOGY QUALITY CONTROL |
| CGL | ELECTRODE, ION BASED, ENZYMATIC, CREATININE |
| CGZ | ELECTRODE, ION-SPECIFIC, CHLORIDE |
| GKR | SYSTEM, HEMOGLOBIN, AUTOMATED |
| JIX | CALIBRATOR, MULTI-ANALYTE MIXTURE |
| JKS | Spectral absorb. Curve, oxyhemoglobin, carboxyhemoglobin, carbon-monoxide |
| GHS | ASSAY, CARBOXYHEMOGLOBIN |
FDA Premarket Submission
| FDA Premarket Submission Number [?] | Supplement Number [?] |
|---|---|
| K061830 | 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 |
Clinically Relevant Size
[?]| Size Type Text |
|---|
| No Device Sizes |
Device Record Status
e39fdbf3-3ac6-4f56-8cb4-71c754a25028
July 06, 2018
3
September 16, 2016
July 06, 2018
3
September 16, 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:
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