DEVICE: STAT PROFILE (00385480485586)

Device Identifier (DI) Information

STAT PROFILE
phox Ultra/CCX
In Commercial Distribution
48558
NOVA BIOMEDICAL CORPORATION
00385480485586
GS1

1
070617139 *Terms of Use
Stat Profile pHOx Ultra/CCX Sensor Blank
CLOSE

Device Characteristics

Labeling does not contain MRI Safety Information
No
No
Yes
Yes
No
No
No
No

GMDN

[?]

GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name GMDN Definition
Metabolic profile clinical chemistry analyser IVD, portable, semi-automated A portable mains electricity (AC-powered) laboratory instrument, typically with rechargeable batteries for power at point-of-care in acute care settings, 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 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.
CLOSE

FDA Product Code

[?]
Product Code Product Code Name
JGS ELECTRODE, ION SPECIFIC, SODIUM
GGZ OXYHEMOGLOBIN
CEM ELECTRODE, ION SPECIFIC, POTASSIUM
CGA GLUCOSE OXIDASE, GLUCOSE
CHL ELECTRODE MEASUREMENT, BLOOD-GASES (PCO2, PO2) AND BLOOD PH
GHS ASSAY, CARBOXYHEMOGLOBIN
CGL ELECTRODE, ION BASED, ENZYMATIC, CREATININE
JFP ELECTRODE, ION SPECIFIC, CALCIUM
BXX CALIBRATOR, PRESSURE, GAS
GLY OXIMETER TO MEASURE HEMOGLOBIN
CDS ELECTRODE, ION SPECIFIC, UREA NITROGEN
JJB AZO-DYES, COLORIMETRIC, BILIRUBIN & ITS CONJUGATES (URINARY, NON-QUANT.)
GJC ASSAY, SULFHEMOGLOBIN
CGZ ELECTRODE, ION-SPECIFIC, CHLORIDE
CFA ELECTRODE, ION SPECIFIC, MAGNESIUM
JIX CALIBRATOR, MULTI-ANALYTE MIXTURE
GKK CYANOMETHEMOGLOBIN
CLOSE

FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K110648 000
No CLOSE

Sterilization

No
No
Sterilization Method [?]
No Sterilization Methods Found
CLOSE

Storage and Handling

[?]
Storage and Handling
No storage/handling found
CLOSE

Clinically Relevant Size

[?]
Size Type Text
No Device Sizes
CLOSE

Device Record Status

c3ced11c-29ea-4e15-89b9-f1151402ed19
July 06, 2018
3
September 20, 2016
CLOSE

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
CLOSE

Secondary DI

[?]
Issuing Agency [?] Secondary DI Number
No Secondary DIs found
CLOSE

Unit of Use DI

[?]
Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]
No
No
None
CLOSE

Production Identifier(s) in UDI

[?]
Yes
No
Yes
Yes
No CLOSE

Customer Contact

[?]
+1(800)545-6682
info@novabio.com
CLOSE