SEASTAR MEDICAL, INC.

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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

Dialyzer, High Permeability With Or Without Sealed Dialysate System (KDI) (1)

Premarket Exempt

Clear

CLR - 20860113000656 Catalog Number : CLR 2.0

Device Description : The SeaStar CLR 2.0 hemofilter is indicated for use in patients with fluid overl The SeaStar CLR 2.0 hemofilter is indicated for use in patients with fluid overload, uremia and/or electrolyte disturbances associated with oligoanuria acute renal failure. It may also be used when removal of excess fluid is indicated, such as patients in pulmonary edema or congestive heart failure refractory to diuretic therapy.

Device Class : 2

Duns Number: 081470300

Premarket Exempt : No

Product Code : KDI

Prescription Use : Yes

Device Count : 1

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