← 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
Catheter/overtube balloon inflator, single-use FDA UDI
Model / Reference
00884450140130 FDA UDI

Identifiers

Catalog Number
K05-02403 FDA UDI
Primary DI / UDI-DI
00884450140130 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

A reliable and accurate catheter/overtube balloon inflator designed for use in medical procedures, featuring a dedicated manual syringe/plunger or electronic mechanism for inflation/deflation. This single-use device is typically used to inflate and regulate the pressure of invasive devices, such as tamp, endomicroscopy probes.

Similar devices

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

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 555f22a7-d7a1-4726-94a3-101386b686d0 33 fields · synced Jul 11, 2026