DIASOL, INC.

Address:310 S 43RD AVE,Phoenix,AZ,85009,US

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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

Dialysate Concentrate For Hemodialysis (Liquid Or Powder) (KPO) (2)

Premarket Exempt

Clear

DIASOL - B467PC63 Catalog Number : PC18

Device Description : Dialysate Additive 6.3 grams Potassium Chloride increases Potassium by 0.5 mEq/L Dialysate Additive 6.3 grams Potassium Chloride increases Potassium by 0.5 mEq/L when added to 3.785 liters of concentrate proportioned at 1:44

Device Class : 2

Duns Number: 068434658

Premarket Exempt : No

Product Code : KPO

Prescription Use : Yes

Device Count : 1

DIASOL - B467PC98 Catalog Number : PC19

Device Description : Dialysate Additive 9.8 grams Potassium Chloride increases Potassium by 1.0 mEq/L Dialysate Additive 9.8 grams Potassium Chloride increases Potassium by 1.0 mEq/L when added to 3.785 liters of concentrate proportioned at 1:34