← Back to catalogue

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
00884450201169 FDA UDI

Identifiers

Catalog Number
K09-11912 FDA UDI
Primary DI / UDI-DI
00884450201169 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 pre-assembled, single-use device designed for the administration of contrast media during diagnostic imaging procedures. This kit is composed of a sterile tubing system with switches/valves and connectors to syringes/fluid/contrast medium injection system, allowing for the safe and effective delivery of a contrast medium and/or saline solution.

Similar devices

Also classified as Contrast medium injection system administration set.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
Merit Medical Systems, Inc.

Sources (1)

  • FDA UDI b250454e-6d8e-4b69-8342-ecf91f8e4cfe 33 fields · synced Jul 18, 2026