FDA.report

Nova

Primary DI
00385480145756
Brand
Nova
Company
NOVA BIOMEDICAL CORPORATION
Model
14
Catalog number
14575
Device description
NOVA 14 TUBING HARNESS WITH DILUTOR
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
false

Related Records

Contact Domains

Product Codes

CodeName
CGAGLUCOSE OXIDASE, GLUCOSE

Product Code Classifications

CodeDeviceSpecialtyClass
CGAGlucose Oxidase, GlucoseClinical Chemistry2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00385480145756PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00385480145756003854801457563854801457560385480145756

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

Other Devices From This Company

Primary DIBrandModelCatalogPublished
00385480636858StatStrip63685636852024-03-28
20385480534936NOVAMAX PLUS KETONE534932016-09-20
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
00385480632300Nova PrimaryNova Primary Glucose Membrane 632302023-02-22
00385480631679Nova PrimaryNova Primary Calibrator Cartridge 150 Sample 631672023-02-09
00385480632317Nova PrimaryNova Primary Glucose Sensor 632312023-02-09
00385480631624Nova PrimaryNova Primary Calibrator Cartridge 450 Sample 631622023-02-08
10385480634578Nova PrimaryNova Primary Analyzer634572023-02-08
00385489038738NovaNova38732022-12-07
00385489388468NovaNova388462022-12-07
00385489388833NovaNova388832022-12-07
00385489400894NovaNova400892022-12-07
00385489485907NovaNova485902022-12-07
00385480616218Stat ProfilePrime Plus616212022-12-07
00385480634120NovaNova634122022-12-07
10385480616055Stat Profile Prime Plus 616052022-06-16
10385480642511Stat ProfilePrime 642512022-04-27
10385480646045Stat ProfilePrime Plus 646042022-04-27

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
00850080988107AUVONUAN HEALTHCARE LIMITEDCGA2026-03-02
00810079240562Teladoc Health, Inc.Teladoc Health, Inc.CGA2026-02-17
00810079240609Teladoc Health, Inc.Teladoc Health, Inc.CGA2026-02-17
00850080988046AUVONUAN HEALTHCARE LIMITEDCGA2026-02-06
00850080988077AUVONUAN HEALTHCARE LIMITEDCGA2026-02-06
MHC1101665140EasyTouchMHC MEDICAL PRODUCTS, LLCCGA2026-01-07
MHC18073000EasyTouchMHC MEDICAL PRODUCTS, LLCCGA2026-01-07
00810079240432Teladoc Health, Inc.Teladoc Health, Inc.CGA2025-09-25
10311917064632WalgreensWALGREEN CO.CGA2025-06-20
00840423500684VivaGuard Ino Blood Glucose Test StripsABOUND Diagnostics, Inc.CGA2025-06-06
10673486013580Teco Diagnostics TC Matrix Clinical Chemistry AnalyzerTECO DIAGNOSTICSCGA2025-05-28
10673486013726Teco Diagnostics TC Matrix Clinical Chemistry AnalyzerTECO DIAGNOSTICSCGA2025-05-28
10673486013894Teco Diagnostics TC Matrix Clinical Chemistry AnalyzerTECO DIAGNOSTICSCGA2025-05-28
10673486013962Teco Diagnostics TC Matrix Clinical Chemistry AnalyzerTECO DIAGNOSTICSCGA2025-05-28
16971292003400AUVONShenzhen Yuwen E-Commerce Co., Ltd.CGA2025-03-14
16971292003417AUVONShenzhen Yuwen E-Commerce Co., Ltd.CGA2025-03-14
00198715270303Pro Comfort Blood Glucose Monitor KitCare Living Diagnostics Inc.CGA2025-02-25
10194346219251ReliOn™ Premier Blood Glucose Test StripsWAL-MART STORES, INC.CGA2025-02-11
10194346219268ReliOn™ Premier Blood Glucose Test StripsWAL-MART STORES, INC.CGA2025-02-11
10673486000726Teco Diagnostics Glucopad Blood Glucose Test StripsTECO DIAGNOSTICSCGA2024-12-19
16971292003134AUVONShenzhen Yuwen E-Commerce Co., Ltd.CGA2024-11-22
16971292003141AUVONShenzhen Yuwen E-Commerce Co., Ltd.CGA2024-11-22
16971292003158AUVONShenzhen Yuwen E-Commerce Co., Ltd.CGA2024-11-22
16971292003165AUVONShenzhen Yuwen E-Commerce Co., Ltd.CGA2024-11-22
16971292003172AUVONShenzhen Yuwen E-Commerce Co., Ltd.CGA2024-11-22
16971292003189AUVONShenzhen Yuwen E-Commerce Co., Ltd.CGA2024-11-22
16971292003196AUVONShenzhen Yuwen E-Commerce Co., Ltd.CGA2024-11-22
16971292003226AUVONShenzhen Yuwen E-Commerce Co., Ltd.CGA2024-11-22
16971292006951AUVONShenzhen Yuwen E-Commerce Co., Ltd.CGA2024-08-14
16971292006968AUVONShenzhen Yuwen E-Commerce Co., Ltd.CGA2024-08-14