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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
00884450292563 FDA UDI

Identifiers

Catalog Number
K09T-11170 FDA UDI
Primary DI / UDI-DI
00884450292563 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

At Merit Medical, we offer a comprehensive contrast medium injection system administration set designed for the safe and effective delivery of contrast media and saline solutions during diagnostic imaging procedures. This disposable device consists of tubing with switches/valves and connectors to syringes/fluid/contrast medium injection systems, making it ideal for multiple patients before being discarded. Our Contrast Medium Injection System Administration Set is a sterile, single-use product that meets the highest standards of quality and safety.

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 63d32bc2-f5f4-43ab-86d3-79a5f40242c9 33 fields · synced Jul 15, 2026