Ibt Scientific LLC

Address:2931 Moose Trl,ELKHART,IN,46514,US

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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

System, Dialysate Delivery, Single Patient (FKP) (5) Dialyzer Reprocessing System (LIF) (1)

Premarket Exempt

Clear

WaterCheck2 - G212CM20201 Catalog Number :

Device Description : 1 bottle of 100 test strips to check residual chlorine in rinse water

Device Class : 2

Duns Number: 016808871

Premarket Exempt : No

Product Code : FKP

Prescription Use : No

Device Count : 1

WaterCheckCP - G212CP20101 Catalog Number :

Device Description : 1 bottle of 100 test strips to test residual Chlorine in rinse water

Device Class : 2

Duns Number: 016808871

Premarket Exempt : No

Product Code : FKP

Prescription Use : No

Device Count : 1

GlutarTest 1 - G212GT23101 Catalog Number :

Device Description : 1 bottle of 100 test strips to test glutaraldehyde

Device Class : 2

Duns Number: 016808871

Premarket Exempt : No

Product Code : LIF

Prescription Use : No

Device Count : 1

Peracid Test - G212HP20401 Catalog Number :

Device Description : 1 bottle of 100 test strips to detect peracetic acid

Device Class : 2

Duns Number: 016808871

Premarket Exempt : No

Product Code : FKP

Prescription Use : No

Device Count : 1

RenalCheck PX - G212PX20501 Catalog Number :

Device Description : 1 bottle of 100 test strips to check peroxide residue in rinse water

Device Class : 2

Duns Number: 016808871

Premarket Exempt : No

Product Code : FKP

Prescription Use : No

Device Count : 1

WaterCheckRC - G212RC22101 Catalog Number :

Device Description : 1 bottle has 100 test strips for testing residual chlorine in rinse water

Device Class : 2

Duns Number: 016808871

Premarket Exempt : No

Product Code : FKP

Prescription Use : No

Device Count : 1

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