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Exeltra Dialyzer

FDA UDI

Class II (US FDA UDI)

by Baxter International Inc.

Identity

Trade Name
Exeltra Dialyzer FDA UDI
Generic Name
Hollow-fibre haemodialysis dialyser, single-use FDA UDI
Device Name
Hemodialysis with EXELTRA and EXELTRA Plus dialyzers is indicated for patients with acute or chronic renal failure when conservative therapy is judged to be inadequate. It also may be indicated in the treatment of patients intoxicated with poisons or drugs. FDA UDI
Model / Reference
170 FDA UDI
Description
Hemodialysis with EXELTRA and EXELTRA Plus dialyzers is indicated for patients with acute or chronic renal failure when conservative therapy is judged to be inadequate. It also may be indicated in the treatment of patients intoxicated with poisons or drugs. FDA UDI

Identifiers

Catalog Number
5M2120 FDA UDI
Primary DI / UDI-DI
00085412071213 FDA UDI
FDA Product Code
KDI FDA UDI
GMDN Term
Hollow-fibre haemodialysis dialyser, single-use 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

Exeltra Dialyzer by Baxter International Inc. — 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
Baxter International Inc.

Sources (1)

  • FDA UDI efd6a472-900e-4d12-89a1-71ebfa6b59e6 37 fields · synced May 30, 2026