Lifehealth

Lifehealth

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Filters

Device Class

Class-1 (A medical device with low to moderate risk that requires general controls) Class-2 (A medical device with a moderate to high risk that requires special controls) Class-3 (A medical device with high risk that requires premarket approval) Class-U (Unclassified)

Product Code

Electrode, Ion Specific, Potassium (CEM) (4) Electrode, Ion Specific, Sodium (JGS) (4) Centrifuge, Hematocrit (GKG) (3) Acid, Lactic, Enzymatic Method (KHP) (2) Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph (CHL) (2) Electrode, Ion Specific, Calcium (JFP) (2) Electrode, Ion-Specific, Chloride (CGZ) (2) Enzymatic Method, Creatinine (JFY) (2) Single (Specified) Analyte Controls (Assayed And Unassayed) (JJX) (1) Electrode, Ion Specific, Urea Nitrogen (CDS) (1) Glucose Oxidase, Glucose (CGA) (1)

Premarket Exempt

No

Clear

CC Cartridge - 00856522006002 Catalog Number : 039903

Device Description : CC Cartridge, 25 count

Device Class : 2

Duns Number: 080886029

Premarket Exempt : No

Product Code : GKG, JGS, CEM, JFP, CHL

Prescription Use : No

Device Count : 25

BG Cartridge - 00856522006019 Catalog Number : 048103

Device Description : BG Cartridge, 25 count

Device Class : 2

Duns Number: 080886029

Premarket Exempt : No

Product Code : CHL

Prescription Use : No

Device Count : 25

H3 Cartridge - 00856522006026 Catalog Number : 048400

Device Description : H3 Cartridge, 25 count

Device Class :

Duns Number: 080886029

Premarket Exempt : No

Product Code : JGS, JFP, GKG, CEM

Prescription Use : No

Device Count : 25

H4 Cartridge - 00856522006033 Catalog Number : 055704

Device Description : H4 Cartridge, 25 count

Device Class :

Duns Number: 080886029

Premarket Exempt : No

Product Code : JGS, GKG, CGZ, CEM, CDS

Prescription Use : No

Device Count : 25

LA Cartridge - 00856522006040 Catalog Number : 070800

Device Description : LA Cartridge, 25 count

Device Class :

Duns Number: 080886029

Premarket Exempt : No

Product Code : KHP

Prescription Use : No

Device Count : 25

CR Cartridge - 00856522006057 Catalog Number : 074400

Device Description : CR Cartridge, 25 count

Device Class :

Duns Number: 080886029

Premarket Exempt : No

Product Code : JFY

Prescription Use : No

Device Count : 25

CR Cartridge - 00856522006064 Catalog Number : 074415

Device Description : CR Cartridge, 10 count

Device Class :

Duns Number: 080886029

Premarket Exempt : No

Product Code : JFY

Prescription Use : No

Device Count : 10

LA Cartridge - 00856522006071 Catalog Number : 070810

Device Description : LA Cartridge, 10 count

Device Class :

Duns Number: 080886029

Premarket Exempt : No

Product Code : KHP

Prescription Use : No

Device Count : 10

GL Cartridge - 00856522006088 Catalog Number : 065202

Device Description : GL Cartridge, 25 count

Device Class : 2

Duns Number: 080886029

Premarket Exempt : No

Product Code : JGS, CEM, CGZ, CGA

Prescription Use : No

Device Count : 25

Creatinine Control Kit - 00856522006095 Catalog Number : 074402

Device Description : Creatinine Control Kit

Device Class : 1

Duns Number: 080886029

Premarket Exempt : No

Product Code : JJX

Prescription Use : No

Device Count : 1

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