FDA.reportPublic FDA data

H4 Cartridge

Primary DI
00856522006033
Brand
H4 Cartridge
Company
Lifehealth
Model
054330
Catalog number
055704
Device description
H4 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
CDSElectrode, Ion Specific, Urea Nitrogen
CEMElectrode, Ion Specific, Potassium
CGZElectrode, Ion-Specific, Chloride
GKGCentrifuge, Hematocrit
JGSElectrode, Ion Specific, Sodium

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
CDSElectrode, Ion Specific, Urea NitrogenClinical Chemistry2
CEMElectrode, Ion Specific, PotassiumClinical Chemistry2
CGZElectrode, Ion-Specific, ChlorideClinical Chemistry2
GKGCentrifuge, HematocritHematology2
JGSElectrode, Ion Specific, SodiumClinical Chemistry2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00856522006033PrimaryGS10
00856522006156Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00856522006033008565220060338565220060330856522006033
00856522006156008565220061568565220061560856522006156

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
00856522006040LA Cartridge0787700708002016-09-24
00856522006071LA Cartridge0787700708102016-09-24
00856522006088GL Cartridge0676600652022016-09-24

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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05700693930985ABL90 FLEX PLUSRadiometer Medical ApSCEM2026-07-09
05700693930985ABL90 FLEX PLUSRadiometer Medical ApSJGS2026-07-09
05700693930985ABL90 FLEX PLUSRadiometer Medical ApSCGZ2026-07-09
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05700699446572SP90Radiometer Medical ApSJGS2026-07-09
05700699446572SP90Radiometer Medical ApSCEM2026-07-09
05700699447579SP90Radiometer Medical ApSCEM2026-07-09
05700699447579SP90Radiometer Medical ApSJGS2026-07-09
05700699447579SP90Radiometer Medical ApSCGZ2026-07-09
05700699461056SC90Radiometer Medical ApSCGZ2026-07-09
05700699461056SC90Radiometer Medical ApSJGS2026-07-09
05700699461056SC90Radiometer Medical ApSCEM2026-07-09
05700699461087SC90Radiometer Medical ApSCEM2026-07-09
05700699461087SC90Radiometer Medical ApSCGZ2026-07-09
05700699461087SC90Radiometer Medical ApSJGS2026-07-09
05700699461094SC90Radiometer Medical ApSJGS2026-07-09
05700699461094SC90Radiometer Medical ApSCGZ2026-07-09
05700699461094SC90Radiometer Medical ApSCEM2026-07-09
05700699461100SC90Radiometer Medical ApSCGZ2026-07-09
05700699461100SC90Radiometer Medical ApSJGS2026-07-09
05700699461100SC90Radiometer Medical ApSCEM2026-07-09
05700699461131SC90Radiometer Medical ApSCEM2026-07-09
05700699461131SC90Radiometer Medical ApSJGS2026-07-09
05700699461605SC90Radiometer Medical ApSJGS2026-07-09
05700699461605SC90Radiometer Medical ApSCGZ2026-07-09
05700699461605SC90Radiometer Medical ApSCEM2026-07-09
00380740215712AlinityABBOTT LABORATORIESCGZ2025-10-08