FDA.reportPublic FDA data

GL Cartridge

Primary DI
00856522006088
Brand
GL Cartridge
Company
Lifehealth
Model
067660
Catalog number
065202
Device description
GL Cartridge, 25 count
Published
2016-09-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
CEMElectrode, Ion Specific, Potassium
CGAGlucose Oxidase, Glucose
CGZElectrode, Ion-Specific, Chloride
JGSElectrode, Ion Specific, Sodium

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
CEMElectrode, Ion Specific, PotassiumClinical Chemistry2
CGAGlucose Oxidase, GlucoseClinical Chemistry2
CGZElectrode, Ion-Specific, ChlorideClinical Chemistry2
JGSElectrode, Ion Specific, SodiumClinical Chemistry2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00856522006088PrimaryGS10
00856522006118Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00856522006088008565220060888565220060880856522006088
00856522006118008565220061188565220061180856522006118

GMDN Terms#

Term, Definition table
TermDefinition
Multiple blood gas/haemoximetry/electrolyte analyte IVD, reagentA substance or reactant intended to be used together with a parent IVD to perform a specific function in an assay that is used for the quantitative measurement of multiple blood gas, haemoximetry and/or electrolyte analytes in a clinical sample. Analytes detected may include partial pressure of oxygen (pO2), partial pressure of carbon dioxide (pCO2), pH, sodium, potassium, ionized calcium, chloride, glucose, lactate, total haemoglobin (totHb), haematocrit, and haemoglobin derivatives such as reduced haemoglobin (RHb), methaemoglobin (MetHb), sulfhaemoglobin (SHb).

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
1-651-638-1000cs@lifehealthmed.com

Regulatory Flags#

DUNS number
080886029
Device count
25
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00856522006057CR Cartridge0742200744002016-09-24
00856522006064CR Cartridge0742200744152016-09-24
00856522006095Creatinine Control Kit0744460744022016-09-24
00856522006118CC Cartridge049330039903-102018-04-23
00856522006125BG Cartridge049110048103-102018-04-23
00856522006132H3 Cartridge049220048400-102018-04-23
00856522006002CC Cartridge0493300399032016-09-24
00856522006019BG Cartridge0491100481032016-09-24
00856522006026H3 Cartridge0492200484002016-09-24
00856522006033H4 Cartridge0543300557042016-09-24
00856522006040LA Cartridge0787700708002016-09-24
00856522006071LA Cartridge0787700708102016-09-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04719869706904Tyson Bio AC500 PRO Blood Glucose Monitoring System (Meter Only) (FDA)TYSON BIORESEARCH INC.CGA2026-07-13
04719869706911TysonBio AC500 PRO Blood Glucose Test Strips (50T)TYSON BIORESEARCH INC.CGA2026-07-13
04719869706942Tyson Bio AC500 PRO Control Solution (Level 1) (FDA)TYSON BIORESEARCH INC.CGA2026-07-13
04719869706959Tyson Bio AC500 PRO Control Solution (Level 3) (FDA)TYSON BIORESEARCH INC.CGA2026-07-13
05700693930978ABL90 FLEXRadiometer Medical ApSCGA2026-07-09
05700693930978ABL90 FLEXRadiometer Medical ApSJGS2026-07-09
05700693930978ABL90 FLEXRadiometer Medical ApSCGZ2026-07-09
05700693930978ABL90 FLEXRadiometer Medical ApSCEM2026-07-09
05700693930985ABL90 FLEX PLUSRadiometer Medical ApSCEM2026-07-09
05700693930985ABL90 FLEX PLUSRadiometer Medical ApSJGS2026-07-09
05700693930985ABL90 FLEX PLUSRadiometer Medical ApSCGA2026-07-09
05700693930985ABL90 FLEX PLUSRadiometer Medical ApSCGZ2026-07-09
05700699446572SP90Radiometer Medical ApSCGZ2026-07-09
05700699446572SP90Radiometer Medical ApSJGS2026-07-09
05700699446572SP90Radiometer Medical ApSCEM2026-07-09
05700699446572SP90Radiometer Medical ApSCGA2026-07-09
05700699447579SP90Radiometer Medical ApSCEM2026-07-09
05700699447579SP90Radiometer Medical ApSJGS2026-07-09
05700699447579SP90Radiometer Medical ApSCGA2026-07-09
05700699447579SP90Radiometer Medical ApSCGZ2026-07-09
05700699461056SC90Radiometer Medical ApSCGA2026-07-09
05700699461056SC90Radiometer Medical ApSCEM2026-07-09
05700699461056SC90Radiometer Medical ApSJGS2026-07-09
05700699461056SC90Radiometer Medical ApSCGZ2026-07-09
05700699461087SC90Radiometer Medical ApSCGA2026-07-09
05700699461087SC90Radiometer Medical ApSCEM2026-07-09
05700699461087SC90Radiometer Medical ApSJGS2026-07-09
05700699461087SC90Radiometer Medical ApSCGZ2026-07-09
05700699461094SC90Radiometer Medical ApSJGS2026-07-09
05700699461094SC90Radiometer Medical ApSCGZ2026-07-09