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Merit Medical® Initial Release

by Merit Medical Systems, Inc. 1,000+ variants

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 Number00884450447093 UDI-DI Date1 Aug 2026ListedStatusListed GUDID: in commercial distribution

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Specification

GUDID

Trade Name
Merit Medical®
Generic Name
Contrast medium injection system administration set
Model / Ref / Catalog
Initial Release, K09-02692J
Primary DI / UDI-DI
00884450447093
FDA Product Code
OEZ
GMDN Term
Contrast medium injection system administration set
Device Class
Class II
Regulation Number
870.1200
GUDID distribution status
In Commercial Distribution

Other devices from Merit Medical Systems, Inc.

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Properties

  • Sterile
  • Single Use
  • Prescription Use
  • Convenience Kit
  • Premarket Exempt
  • Lot / Batch Number
  • Expiration Date

Other properties (7)

  • Implantable: No
  • Contains Latex: No
  • Over-the-Counter: No
  • Combination Product: No
  • HCT/P: No
  • Serial Number: No
  • Manufacturing Date: No