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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
Catheter/overtube balloon inflator, single-use FDA UDI
Model / Reference
00884450639238 FDA UDI

Identifiers

Catalog Number
K05-02667A FDA UDI
Primary DI / UDI-DI
00884450639238 FDA UDI
FDA Product Code
OEQ FDA UDI
GMDN Term
Catheter/overtube balloon inflator, single-use FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
870.1650 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: Catheter/overtube balloon inflator, single-use

This Catheter/Overtube Balloon Inflator is a single-use device designed to inflate and regulate the pressure of various invasive devices, including catheters, endoscopic overtubes, and tamp probes. It features a dedicated manual syringe/plunger or electronic mechanism for inflation/deflation, an analogue/digital gauge screen for monitoring pressure, and a locking mechanism. The device is sterilized through heat treatment and is designed for single-use implantation.

Similar devices

Also classified as Catheter/overtube balloon inflator, single-use.

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 be405e47-9895-4fbb-9cde-3de426f4364c 33 fields · synced Jul 11, 2026