Stat Profile

Primary DI: 00385480082976
Brand: Stat Profile
Company: NOVA BIOMEDICAL CORPORATION
Model: 3
Catalog number: 8297
Device description: STAT PROFILE 3 CAPILLARY TUBE KIT 150 uL WITH HEPARIN
Published: 2016-09-20
Public version status: Update
Distribution status: In Commercial Distribution
MRI safety: Labeling does not contain MRI Safety Information
Rx: true
OTC: false
Sterile: false
Single use: true

Related Records

Contact Domains

novabio.com

Product Codes

Code	Name
CHL	ELECTRODE MEASUREMENT, BLOOD-GASES (PCO2, PO2) AND BLOOD PH

Product Code Classifications

Code	Device	Specialty	Class
CHL	Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph	Clinical Chemistry	2

Identifiers And Packaging

Identifier	Type	Agency	Package quantity	Status
00385480082976	Primary	GS1	0
00385489082977	Unit of Use	GS1	0

Alternate GTIN / UPC / EAN Codes

Source identifier	GTIN-14 normalized	UPC-A	EAN-13
00385480082976	00385480082976	385480082976	0385480082976
00385489082977	00385489082977	385489082977	0385489082977

GMDN Terms

Term	Definition
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.

Term

Definition

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.

Sterilization Methods

Method

Contacts

Phone	Email
+1(800)545-6682	info@novabio.com

Regulatory Flags

DUNS number: 070617139
Device count: 100
DM exempt: false
Premarket exempt: false
HCT/P: false
Kit: true
Combination product: false
Lot or batch: true
Serial number: false
Manufacturing date on label: false
Expiration date on label: false
Donation ID number: false
Contains natural rubber latex: false
No natural rubber latex: false
Sterilization required before use: false

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00385480631655	Nova Primary	Nova Primary Linearity Level 1	63165	2023-02-24
00385480631662	Nova Primary	Nova Primary Linearity Level 2	63166	2023-02-24
00385480632300	Nova Primary	Nova Primary Glucose Membrane	63230	2023-02-22
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00385480631624	Nova Primary	Nova Primary Calibrator Cartridge 450 Sample	63162	2023-02-08
10385480634578	Nova Primary	Nova Primary Analyzer	63457	2023-02-08
00385489038738	Nova	Nova	3873	2022-12-07
00385489388468	Nova	Nova	38846	2022-12-07
00385489388833	Nova	Nova	38883	2022-12-07
00385489400894	Nova	Nova	40089	2022-12-07
00385489485907	Nova	Nova	48590	2022-12-07
00385480616218	Stat Profile	Prime Plus	61621	2022-12-07
00385480634120	Nova	Nova	63412	2022-12-07
10385480616055	Stat Profile	Prime Plus	61605	2022-06-16
10385480642511	Stat Profile	Prime	64251	2022-04-27
10385480646045	Stat Profile	Prime Plus	64604	2022-04-27

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