FDA.report

NOVA

Primary DI
00385480131964
Brand
NOVA
Company
NOVA BIOMEDICAL CORPORATION
Model
1/5/11/13
Catalog number
13196
Device description
NOVA 1/5/11/13 W/R PUMP TUBE WITHOUT DILUTOR
Published
2016-09-16
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
false

Related Records

Contact Domains

Product Codes

CodeName
CEMELECTRODE, ION SPECIFIC, POTASSIUM

Product Code Classifications

CodeDeviceSpecialtyClass
CEMElectrode, Ion Specific, PotassiumClinical Chemistry2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00385480131964PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00385480131964003854801319643854801319640385480131964

GMDN Terms

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

TypeLowHighCondition
Handling Environment Temperature15 Degrees Celsius30 Degrees Celsius
Storage Environment Temperature15 Degrees Celsius30 Degrees Celsius

Sterilization Methods

Method

Contacts

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

Regulatory Flags

DUNS number
070617139
Device count
1
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
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
06936415904661MR Na/K Check SolutionShenzhen Mindray Bio-Medical Electronics Co., Ltd.CEM2026-01-23
03701700860419SelectraVitalScientific B.V.CEM2025-05-06
07613336227770Potassium electrodeRoche Diagnostics GmbHCEM2025-03-05
07613336227794Reference electrodeRoche Diagnostics GmbHCEM2025-03-05
07640172344002FlexLab XInpeco SACEM2024-07-30
05700699460509SC90 50 BG, LYT, MET, OXI + QCRadiometer Medical ApSCEM2024-07-01
03661540304156Potassium ElectrodeELITECHGROUP INC.CEM2023-10-01
00811403012558Potassium ElectrodeDiamond Diagnostics Inc.CEM2023-06-12
00811403015931Sample DetectorDiamond Diagnostics Inc.CEM2023-06-06
00811403015948Membrane AssemblyDiamond Diagnostics Inc.CEM2023-06-06
00811403010127Potassium ElectrodeDiamond Diagnostics Inc.CEM2023-06-05
00811403015788Potassium ElectrodeDiamond Diagnostics Inc.CEM2023-06-05
00811403019892SmartLyte Electrolyte AnalyzerDiamond Diagnostics Inc.CEM2023-06-05
04015630028689Roche 9180 Potassium electrodeRoche Diagnostics GmbHCEM2021-07-30
04987762129865Potassium ElectrodeJEOL LTD.CEM2020-09-15
04580262010277K ElectrodeTOKYO BOEKI MEDISYS INC.CEM2019-09-30
00894472000244OPTI CCA E CassetteOPTI MEDICAL SYSTEMS, INC.CEM2019-08-07
00850229007331SelectaLyte (Potassium Electrode)AWARENESS TECHNOLOGY, INCORPORATEDCEM2019-06-26
00386100001643ISE Potassium Electrode MEDICA CORPORATIONCEM2018-12-11
00386100002466Potassium ElectrodeMEDICA CORPORATIONCEM2018-12-05
00386100002398Daily Cleaning Solution Kit MEDICA CORPORATIONCEM2018-12-04
00386100002862Na/K AnalyzerMEDICA CORPORATIONCEM2018-12-04
00386100002985Reference ElectrodeMEDICA CORPORATIONCEM2018-12-04
00386100003029Na/K Solution PackMEDICA CORPORATIONCEM2018-12-04
00386100003081Na/K Solution Pack MEDICA CORPORATIONCEM2018-12-04
00386100003173Membrane Assembly MEDICA CORPORATIONCEM2018-12-04
00386100003180Capillary Adapter Cleaning Kit MEDICA CORPORATIONCEM2018-12-04
00386100003197Capillary tubesMEDICA CORPORATIONCEM2018-12-04
00386100003203Wash Solution MEDICA CORPORATIONCEM2018-12-04
00386100003210Internal Filling SolutionMEDICA CORPORATIONCEM2018-12-04