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Molded Products, Inc.

FDA UDI

Class II (US FDA UDI)

by Molded Products Inc.

Identity

Trade Name
Molded Products, Inc. FDA UDI
Generic Name
Hollow-fibre haemodialysis dialyser, reusable FDA UDI
Device Name
Dialysate Port to Blood Circulation Line with Adjustable Pulse Control for Pre-Rinse Only FDA UDI
Model / Reference
MPC-671 FDA UDI
Description
Dialysate Port to Blood Circulation Line with Adjustable Pulse Control for Pre-Rinse Only FDA UDI

Identifiers

Catalog Number
MPC-671 FDA UDI
Primary DI / UDI-DI
B144MPC6711 FDA UDI
510(k) Number
K022068 FDA UDI
FDA Product Code
FID FDA UDI
GMDN Term
Hollow-fibre haemodialysis dialyser, reusable FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
876.5820 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

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

No

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Hollow-fibre haemodialysis dialyser, reusable

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

Similar devices

Also classified as Hollow-fibre haemodialysis dialyser, reusable.

Cleared under the same submission

K022068 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Molded Products Inc.

Sources (1)

  • FDA UDI 4ec8af13-d94d-4969-ae47-0d76470a05ed 35 fields · synced Jun 8, 2026