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Elation™ 00884450198032

by Merit Medical Systems, Inc.

Elation™ 00884450198032 (P12L55) is a Class II device made by Merit Medical Systems, Inc., listed in FDA GUDID since 27 Jan 2017 (UDI-DI 00884450198032), registry data as of 23 Oct 2026.

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None

No authorization documents

Trust

Unverified

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00884450198032 UDI-DI Date27 Jan 2017ListedStatusListed GUDID: in commercial distribution

Official records

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — GUDID listing Listed

Specification

GUDID

Trade name
Elation™
Generic name
Bronchial balloon catheter
Model / Ref / Catalog
00884450198032, P12L55
Primary DI / UDI-DI
00884450198032
FDA product code
KTI
GMDN term
Bronchial balloon catheter
Device class
Class II
Regulation number
874.4680
GUDID distribution status
In Commercial Distribution

Related devices

Category: Bronchial balloon catheter

Similar devices

Other devices filed under FDA product code KTI (BRONCHOSCOPE ACCESSORY).

Other devices from Merit Medical Systems, Inc.

See all devices from Merit Medical Systems, Inc. →

Properties

  • Supplied sterile
  • Single use
  • Lot / batch number
  • Expiration date
Other properties (11, all answered No)