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Merit Medical®

FDA UDI

Class II (US FDA UDI)

by Merit Medical Systems, Inc.

Identity

Trade Name
Merit Medical® FDA UDI
Generic Name
Contrast medium injection system administration set FDA UDI
Model / Reference
00884450292679 FDA UDI

Identifiers

Catalog Number
K09-12556B FDA UDI
Primary DI / UDI-DI
00884450292679 FDA UDI
FDA Product Code
OEZ FDA UDI
GMDN Term
Contrast medium injection system administration set FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
870.1200 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

No

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

Yes

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Contrast medium injection system administration set

Merit Medical's Cardiovascular Procedure Kit is a collection of noninvasive devices designed for the delivery of contrast media and saline solution to patients undergoing diagnostic imaging procedures. This disposable device consists of tubing with switches/valves, connectors, syringes, fluid/injection system, and possibly a pressure transducer. It is made of plastic materials and is typically used once before being discarded. The kit is not implantable and has no labeling indicating MRI safety information.

Similar devices

Also classified as Contrast medium injection system administration set.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Merit Medical Systems, Inc.

Sources (1)

  • FDA UDI 3a828c2b-e8d9-4ce5-bd88-eb9d172c9af3 33 fields · synced Jul 9, 2026