FDA.report

NOVA

Primary DI
10385480140628
Brand
NOVA
Company
NOVA BIOMEDICAL CORPORATION
Model
4/5/12/13/14
Catalog number
14062
Device description
NOVA 4/5/12/13/14 CHLORIDE SENSOR
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

Product Codes

CodeName
CGZELECTRODE, ION-SPECIFIC, CHLORIDE

Product Code Classifications

CodeDeviceSpecialtyClass
CGZElectrode, Ion-Specific, ChlorideClinical Chemistry2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
10385480140628PackageGS14In Commercial Distribution
00385480140621PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
1038548014062810385480140628
00385480140621003854801406213854801406210385480140621

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
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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