← Back to catalogue

Elation 5™

FDA UDI

Class II (US FDA UDI)

by Merit Medical Systems, Inc.

Identity

Trade Name
Elation 5™ FDA UDI
Generic Name
Gastrointestinal/biliary dilation balloon catheter, non-medicated FDA UDI
Model / Reference
00884450487068 FDA UDI

Identifiers

Catalog Number
EPX6 FDA UDI
Primary DI / UDI-DI
00884450487068 FDA UDI
FDA Product Code
KNQ FDA UDI
GMDN Term
Gastrointestinal/biliary dilation balloon catheter, non-medicated FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
876.5365 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

No

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: Gastrointestinal/biliary dilation balloon catheter, non-medicated

The Elation 5 device is a single-use, non-medicated gastrointestinal/biliary dilation balloon catheter designed for use in procedures to widen strictures of the oesophagus, pylorus, colon, and/or biliary tract. It features an inflatable balloon at its distal tip, typically used for endoscopic dilatation. This device has been approved by regulatory agencies such as FDA for commercial distribution. For more detailed information on this product, please consult the Merit Medical Systems, Inc., manufacturer.

Similar devices

Also classified as Gastrointestinal/biliary dilation balloon catheter, non-medicated.

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 4a13c33e-13a1-4c7e-ac83-cd8024200932 34 fields · synced Oct 7, 2026