AccessGUDID - DEVICE: STAT PROFILE (00385480225076)

GUDID

Device Identifier (DI) Information

Brand Name: STAT PROFILE
Version or Model: pHOx/BASIC/PLUS/L/C
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 22507
Company Name: NOVA BIOMEDICAL CORPORATION

Primary DI Number: 00385480225076
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 070617139 *Terms of Use

Device Description: STAT PROFILE pHOx/BASIC/PLUS/L/C SENSOR

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:	Yes
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?
56672	Blood gas/haemoximetry analyser IVD, point-of-care	A mains electricity (AC-powered) instrument intended to be used by health professionals at the point-of-care, and often in the laboratory, for the quantitative in vitro measurement of blood pH, partial pressure of oxygen (pO2) and/or partial pressure of carbon dioxide (pCO2), and the measurement or calculation of other blood gas and co-oximetry parameters [e.g., bicarbonate (HCO3-), base excess, arterial-alveolar gradient, oxyhaemoglobin (O2Hb), deoxyhaemoglobin (HHb) or reduced haemoglobin (RHb), carboxy-haemoglobin (COHb), methaemoglobin (MetHb), sulfhaemoglobin (SHb), and total haemoglobin (totHb)] in a clinical specimen.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
CGZ	ELECTRODE, ION-SPECIFIC, CHLORIDE
JKS	Spectral absorb. Curve, oxyhemoglobin, carboxyhemoglobin, carbon-monoxide
JPK	MIXTURE, HEMATOLOGY QUALITY CONTROL
KHP	ACID, LACTIC, ENZYMATIC METHOD
JFP	ELECTRODE, ION SPECIFIC, CALCIUM
CEM	ELECTRODE, ION SPECIFIC, POTASSIUM
GJS	TEST, TIME, PROTHROMBIN
JIX	CALIBRATOR, MULTI-ANALYTE MIXTURE
CHL	ELECTRODE MEASUREMENT, BLOOD-GASES (PCO2, PO2) AND BLOOD PH
GKR	SYSTEM, HEMOGLOBIN, AUTOMATED
JPI	DEVICE, HEMATOCRIT MEASURING

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: 02676fe8-d950-41a0-9313-8c72558ab461
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: September 20, 2016