DEVICE: STAT PROFILE (00385480498470)

Device Identifier (DI) Information

STAT PROFILE
PHOX/BASIC/BIOPHOX
In Commercial Distribution
49847
NOVA BIOMEDICAL CORPORATION
00385480498470
GS1

1
070617139 *Terms of Use
Stat Profile pHOx/Basic/BiopHOx W/R Pump Tubing Kit
CLOSE

Device Characteristics

Labeling does not contain MRI Safety Information
No
No
No
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
Blood gas 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 calculation of other blood gas parameters [e.g., bicarbonate (HCO3-), base excess, arterial-alveolar gradient] in a clinical specimen.
CLOSE

FDA Product Code

[?]
Product Code Product Code Name
JPI DEVICE, HEMATOCRIT MEASURING
JIX CALIBRATOR, MULTI-ANALYTE MIXTURE
CHL ELECTRODE MEASUREMENT, BLOOD-GASES (PCO2, PO2) AND BLOOD PH
JKS Spectral absorb. Curve, oxyhemoglobin, carboxyhemoglobin, carbon-monoxide
JPK MIXTURE, HEMATOLOGY QUALITY CONTROL
GKR SYSTEM, HEMOGLOBIN, AUTOMATED
CLOSE

FDA Premarket Submission

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

0e81d97c-da77-46a5-a6ef-95c6cf44cb07
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