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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
Haemodialysis system, institutional FDA UDI
Device Name
Female Hansen Quick Disconnect - Straight Barb fits 3/8" Tubing, Red FDA UDI
Model / Reference
MPC-1014-R FDA UDI
Description
Female Hansen Quick Disconnect - Straight Barb fits 3/8" Tubing, Red FDA UDI

Identifiers

Catalog Number
MPC-1014-R FDA UDI
Primary DI / UDI-DI
B144MPC1014R2 FDA UDI
510(k) Number
K022068 FDA UDI
FDA Product Code
FID FDA UDI
GMDN Term
Haemodialysis system, institutional 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

No

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: Haemodialysis system, institutional

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

Similar devices

Also classified as Haemodialysis system, institutional.

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 dfea5b2c-5241-4ced-8217-5c4241f7b6e5 35 fields · synced Jun 8, 2026