AccessGUDID - DEVICE: STAT PROFILE (00385480248198)

GUDID

Device Identifier (DI) Information

Brand Name: STAT PROFILE
Version or Model: CCX/PHOX/BASIC/PLUS/L/C
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 24819
Company Name: NOVA BIOMEDICAL CORPORATION

Primary DI Number: 00385480248198
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 070617139 *Terms of Use

Device Description: Stat Profile CCX Stat Profile pHOx/Basic/Plus/L/C/M Control Flush Fixture

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

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
CGA	GLUCOSE OXIDASE, GLUCOSE
JIX	CALIBRATOR, MULTI-ANALYTE MIXTURE
CGZ	ELECTRODE, ION-SPECIFIC, CHLORIDE
CDS	ELECTRODE, ION SPECIFIC, UREA NITROGEN
GHS	ASSAY, CARBOXYHEMOGLOBIN
CGL	ELECTRODE, ION BASED, ENZYMATIC, CREATININE
JGS	ELECTRODE, ION SPECIFIC, SODIUM
CHL	ELECTRODE MEASUREMENT, BLOOD-GASES (PCO2, PO2) AND BLOOD PH
JPI	DEVICE, HEMATOCRIT MEASURING
GKR	SYSTEM, HEMOGLOBIN, AUTOMATED
JFP	ELECTRODE, ION SPECIFIC, CALCIUM
KHP	ACID, LACTIC, ENZYMATIC METHOD
JPK	MIXTURE, HEMATOLOGY QUALITY CONTROL
GJS	TEST, TIME, PROTHROMBIN
CFA	ELECTRODE, ION SPECIFIC, MAGNESIUM
CEM	ELECTRODE, ION SPECIFIC, POTASSIUM
JKS	Spectral absorb. Curve, oxyhemoglobin, carboxyhemoglobin, carbon-monoxide
JJS	CONTROLS FOR BLOOD-GASES, (ASSAYED AND UNASSAYED)

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K014295	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 546ec9e6-dcad-4f73-a016-7ce0a3f3d4c7
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: September 20, 2016