FDA.reportPublic FDA data

NOVA

Primary DI
10385480215883
Brand
NOVA
Company
NOVA BIOMEDICAL CORPORATION
Model
16
Catalog number
21588
Device description
NOVA 16 TCO2 MEMBRANE CAPS
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

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
10385480215883PackageGS12In Commercial Distribution
00385480215886PrimaryGS10
00385489215887Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1038548021588310385480215883
00385480215886003854802158863854802158860385480215886
00385489215887003854892158873854892158870385489215887

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
3
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
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

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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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
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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