FDA.reportPublic FDA data

Nova

Primary DI
00385480001014
Brand
Nova
Company
NOVA BIOMEDICAL CORPORATION
Model
1
Catalog number
101
Device description
TCO2Internal Filling Solution
Published
2016-09-16
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
JFLPH RATE MEASUREMENT, CARBON-DIOXIDE

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JFLPh Rate Measurement, Carbon-DioxideClinical Chemistry2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K963005000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K963005000NOVA 16 ANALYZER (MODIFICATION POINT OF CARE USAGE)Nova Biomedical Corp.1996-08-23JFL

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00385480001014PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00385480001014003854800010143854800010140385480001014

GMDN Terms#

Term, Definition table
TermDefinition
Metabolic profile clinical chemistry analyser IVD, portable, semi-automatedA 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.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Temperature15 Degrees Celsius30 Degrees Celsius
Storage Environment Temperature15 Degrees Celsius30 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
070617139
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00385480657365StatSensor StatStripGen 2.0657362026-05-06
00385480667678StatSensor StatStripGeen 2.0667672026-05-06
00385480667685StatSensor StatStripGen 2.0667682026-05-06
10385480632307Nova PrimaryNova Primary Glucose Membrane 632302023-02-22
00385480632317Nova PrimaryNova Primary Glucose Sensor 632312023-02-09
00385480533980STATSTRIP1.75533982016-09-20
00385480533997STATSTRIP1.75533992016-09-20
00385480547901STATSTRIP1.86547902016-09-16
00385480636858StatStrip63685636852024-03-28
10385480534939NOVAMAX PLUS KETONE534932016-09-20
00385480434355Nova MaxPlus434352016-09-20
00385480434362Nova MaxPlus434362016-09-20
00385480458245Nova MaxPlus458242016-09-20
20385480534936NOVAMAX PLUS KETONE534932016-09-20
10385480631645Nova PrimaryNova Primary Ampuled Control 1, 2631642023-02-24
10385480631652Nova PrimaryNova Primary Linearity Level 1 631652023-02-24
10385480631669Nova Primary Nova Primary Linearity Level 2631662023-02-24
00385480631648Nova PrimaryNova Primary Ampuled Control 1, 2631642023-02-24
00385480631655Nova PrimaryNova Primary Linearity Level 1 631652023-02-24
00385480631662Nova Primary Nova Primary Linearity Level 2631662023-02-24

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Primary DI, Brand, Company table
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00817302024012CAROLINA LIQUID CHEMISTRIES CORP.® FAST DETERGENT 2 ACID WASHING SOLUTION 100262CAROLINA LIQUID CHEMISTRIES CORPORATIONJFL2022-07-06
00630414606460epoc Host2Epocal IncJFL2020-07-15
00630414606095epoc NXS HostEpocal IncJFL2020-06-18
10054749005519i-STATABBOTT POINT OF CARE INC.JFL2020-05-01
04050659367975mahe medical GmbHmahe medical gmbhJFL2019-11-05
04050659368057mahe medical GmbHmahe medical gmbhJFL2019-11-05
04050659368217mahe medical GmbHmahe medical gmbhJFL2019-11-05
04050659368293mahe medical GmbHmahe medical gmbhJFL2019-11-05
04050659368828mahe medical GmbHmahe medical gmbhJFL2019-11-05
04050659371248mahe medical GmbHmahe medical gmbhJFL2019-11-05
04050659371682mahe medical GmbHmahe medical gmbhJFL2019-11-05
04050659371743mahe medical GmbHmahe medical gmbhJFL2019-11-05
04050659371750mahe medical GmbHmahe medical gmbhJFL2019-11-05
04050659372214mahe medical GmbHmahe medical gmbhJFL2019-11-05
04050659372276mahe medical GmbHmahe medical gmbhJFL2019-11-05
04050659373631mahe medical GmbHmahe medical gmbhJFL2019-11-05
04050659373655mahe medical GmbHmahe medical gmbhJFL2019-11-05
04050659373693mahe medical GmbHmahe medical gmbhJFL2019-11-05
EMAH3601319SL0HF-roller ball resectoscopy electrode, roller diam.3.0mm,24Chmahe medical gmbhJFL2018-12-10
EMAH3500915QL0Lithotripsy Telescope bridge w.7Ch. working channelmahe medical gmbhJFL2018-02-05
00630414596518Atellica A-LYTE™ Integrated Multisensor Na+ / K+ / Cl-Siemens Healthcare Diagnostics Inc.JFL2017-12-22
00385480183420NOVANOVA BIOMEDICAL CORPORATIONJFL2017-04-24
EMAH36014240Roller barrel resectoscopy electrode, 24Ch.,roller diam.3.0mmmahe medical gmbhJFL2017-02-09
00842768014017Dimension® QuikLYTE® Integrated Multisensor Sample DiluentSiemens Healthcare Diagnostics Inc.JFL2016-09-24
00842768014024Dimension® QuikLYTE® Integrated Multisensor Diluent CheckSiemens Healthcare Diagnostics Inc.JFL2016-09-24
00842768014291Dimension® QuikLYTE® Multisensor Na+/K+/Cl-Siemens Healthcare Diagnostics Inc.JFL2016-09-24
00842768014307Dimension® QuikLYTE® Multisensor Flush SolutionSiemens Healthcare Diagnostics Inc.JFL2016-09-24
00385480001250NOVANOVA BIOMEDICAL CORPORATIONJFL2016-09-20
00385480215886NOVANOVA BIOMEDICAL CORPORATIONJFL2016-09-20