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Elation™

FDA UDI

Class II (US FDA UDI)

by Merit Medical Systems, Inc.

Identity

Trade Name
Elation™ FDA UDI
Generic Name
Oesophageal balloon catheter FDA UDI
Model / Reference
00884450197776 FDA UDI

Identifiers

Primary DI / UDI-DI
00884450197776 FDA UDI
FDA Product Code
KNQ FDA UDI
GMDN Term
Oesophageal balloon catheter 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: Oesophageal balloon catheter

Elation is a single-use, published device designed to dilate strictures in the esophagus, typically used for oesophageal surgery, primary gastric reflux, radiation therapy, and dilatation of the cardia in patients with achalasia.

Similar devices

Also classified as Oesophageal balloon catheter.

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 0255b42f-f1a5-4faa-a3c4-f5cee3a97242 33 fields · synced Jul 12, 2026