Skip to content

Monarch® 00884450298046

by Merit Medical Systems, Inc.

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

Registry data, not yet checked by deviCERTS. Source GUDID, synced 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00884450298046 UDI-DI Date21 Mar 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  • Withdrawn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
Monarch®
Generic name
Catheter/overtube balloon inflator, single-use
Model / Ref / Catalog
00884450298046, IN2330/B
Primary DI / UDI-DI
00884450298046
FDA product code
DXT
GMDN term
Catheter/overtube balloon inflator, single-use
Device class
Class II
Regulation number
870.1650
GUDID distribution status
In Commercial Distribution

Related devices

Category: Catheter/overtube balloon inflator, single-use

Other devices from Merit Medical Systems, Inc.

See all devices from Merit Medical Systems, Inc. →

Properties

  • Supplied sterile
  • Single use
  • Convenience kit
  • Lot / batch number
  • Expiration date

Other properties (10)

  • Sterilise before use: No
  • Implantable: No
  • Contains latex: No
  • Prescription use: No
  • Over-the-counter: No
  • Combination product: No
  • HCT/P: No
  • Premarket exempt: No
  • Serial number: No
  • Manufacturing date: No