DEVICE: Stat Profile (00385480407229)
Device Identifier (DI) Information
Stat Profile
CCX
In Commercial Distribution
40722
NOVA BIOMEDICAL CORPORATION
CCX
In Commercial Distribution
40722
NOVA BIOMEDICAL CORPORATION
STAT PROFILE CRITICAL CARE EXPRESS CAPILLARY TUBE 230 uL WITH Na HEPARIN
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 |
|---|---|
| JPK | MIXTURE, HEMATOLOGY QUALITY CONTROL |
| CEM | ELECTRODE, ION SPECIFIC, POTASSIUM |
| CGL | ELECTRODE, ION BASED, ENZYMATIC, CREATININE |
| JFP | ELECTRODE, ION SPECIFIC, CALCIUM |
| CFA | ELECTRODE, ION SPECIFIC, MAGNESIUM |
| JPI | DEVICE, HEMATOCRIT MEASURING |
| CGA | GLUCOSE OXIDASE, GLUCOSE |
| JKS | Spectral absorb. Curve, oxyhemoglobin, carboxyhemoglobin, carbon-monoxide |
| JIX | CALIBRATOR, MULTI-ANALYTE MIXTURE |
| JJS | CONTROLS FOR BLOOD-GASES, (ASSAYED AND UNASSAYED) |
| CGZ | ELECTRODE, ION-SPECIFIC, CHLORIDE |
| CHL | ELECTRODE MEASUREMENT, BLOOD-GASES (PCO2, PO2) AND BLOOD PH |
| CDS | ELECTRODE, ION SPECIFIC, UREA NITROGEN |
| GKR | SYSTEM, HEMOGLOBIN, AUTOMATED |
| KHP | ACID, LACTIC, ENZYMATIC METHOD |
| GHS | ASSAY, CARBOXYHEMOGLOBIN |
| JGS | ELECTRODE, ION SPECIFIC, SODIUM |
FDA Premarket Submission
| FDA Premarket Submission Number [?] | Supplement Number [?] |
|---|---|
| K061830 | 000 |
Sterilization
Storage and Handling
[?]| Storage and Handling |
|---|
| No storage/handling found |
Clinically Relevant Size
[?]| Size Type Text |
|---|
| No Device Sizes |
Device Record Status
d101411c-ccea-4ac9-9fbc-678dbfe303f5
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:
00385489407220
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
+1(800)545-6682
info@novabio.com
info@novabio.com