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Blood Circuit Set

FDA UDI

Class II (US FDA UDI)

by Gambro UF Solutions LLC

Identity

Trade Name
Blood Circuit Set FDA UDI
Generic Name
Haemofilter FDA UDI
Device Name
The Aquadex System is indicated for temporary (up to 8 hours) ultrafiltration treatment of patients with fluid overload who have failed diuretic therapy, and extended (longer than 8 hours) ultrafiltration treatment of patients with fluid overload who have failed diuretic therapy and require hospitalization. FDA UDI
Model / Reference
UF 500-HCT FDA UDI
Description
The Aquadex System is indicated for temporary (up to 8 hours) ultrafiltration treatment of patients with fluid overload who have failed diuretic therapy, and extended (longer than 8 hours) ultrafiltration treatment of patients with fluid overload who have failed diuretic therapy and require hospitalization. FDA UDI

Identifiers

Catalog Number
114157 FDA UDI
Primary DI / UDI-DI
07332414112370 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
Not in Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

Blood Circuit Set by Gambro UF Solutions LLC — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Gambro UF Solutions LLC

Sources (1)

  • FDA UDI f1258b9f-380d-46e3-b0c0-9c09a0f3e93c 37 fields · synced Jun 9, 2026