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Revaclear

FDA UDI

Class II (US FDA UDI)

by Gambro Renal Products, Inc.

Identity

Trade Name
REVACLEAR FDA UDI
Generic Name
Hollow-fibre haemodialysis dialyser, single-use FDA UDI
Device Name
Revaclear 400 dialyzer is indicated for treatment of chronic and acute renal failure by hemodialysis FDA UDI
Model / Reference
400 FDA UDI
Description
Revaclear 400 dialyzer is indicated for treatment of chronic and acute renal failure by hemodialysis FDA UDI

Identifiers

Catalog Number
114746L FDA UDI
Primary DI / UDI-DI
07332414124076 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
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

Yes

FDA UDI

Category: Hollow-fibre haemodialysis dialyser, single-use

Revaclear by Gambro Renal Products, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Hollow-fibre haemodialysis dialyser, single-use.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Gambro Renal Products, Inc.

Sources (1)

  • FDA UDI 3a794490-7924-4d88-ab58-07758b60200d 36 fields · synced Jun 8, 2026