Clr

FDA UDI

Class II (US FDA UDI)

by Seastar Medical, Inc.

Identity

Trade Name: CLR FDA UDI
Generic Name: Haemofilter FDA UDI
Device Name: 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. FDA UDI
Model / Reference: 2.0 FDA UDI
Description: 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. FDA UDI

Identifiers

Catalog Number: CLR 2.0 FDA UDI
Primary DI / UDI-DI: 20860113000656 FDA UDI
510(k) Number: K000028 FDA UDI
FDA Product Code: KDI FDA UDI
GMDN Term: Haemofilter FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 876.5860 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

Sterilization Method

Ethylene Oxide FDA UDI

Dimensions & Sizes

Size: Area/Surface Area — 1.98 Square meter FDA UDI

Category: Haemofilter

Clr by Seastar Medical, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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PRISMAFLEX SET — GAMBRO INDUSTRIES · Class II
PRISMAFLEX SET — GAMBRO INDUSTRIES · Class II
PRISMAFLEX SET — GAMBRO INDUSTRIES · Class II

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

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Manufacturer

Manufacturer: Seastar Medical, Inc.

Sources (1)

FDA UDI 9947ad21-7436-4493-a059-cee2714436f3 37 fields · synced May 30, 2026