Prismaflex

FDA UDI

Class II (US FDA UDI)

by Gambro, Inc.

Identity

Trade Name: Prismaflex FDA UDI
Generic Name: Haemodialysis system, institutional FDA UDI
Device Name: The Prismaflex control unit is a software controlled single patient device that performs Continuous Renal Replacement Therapy and Therapeutic Plasma Exchange Therapy FDA UDI
Model / Reference: 7.XX FDA UDI
Description: The Prismaflex control unit is a software controlled single patient device that performs Continuous Renal Replacement Therapy and Therapeutic Plasma Exchange Therapy FDA UDI

Identifiers

Catalog Number: 115269 FDA UDI
Primary DI / UDI-DI: 07332414117702 FDA UDI
510(k) Number: K131516 FDA UDI
FDA Product Code: KDI FDA UDI
GMDN Term: Haemodialysis system, institutional 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

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Haemodialysis system, institutional

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

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Molded Products, Inc. — MOLDED PRODUCTS INC. · Class II
Molded Products, Inc. — MOLDED PRODUCTS INC. · Class II
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Cleared under the same submission

K131516 also covers:

Prismaflex — Gambro, Inc.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

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Manufacturer

Manufacturer: Gambro, Inc.

Sources (1)

FDA UDI 833b4600-ff90-4645-867f-aa47d6b2d3f0 37 fields · synced May 31, 2026