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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 Number00884450106204 UDI-DI Date28 Oct 2025ListedStatusListed 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  • Withdrawn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
Basic intravenous administration set, noninvasive
Model / Ref / Catalog
Initial Release, K08-01859A
Primary DI / UDI-DI
00884450106204
FDA Product Code
OJA
GMDN Term
Basic intravenous administration set, noninvasive
Device Class
Class II
Regulation Number
880.5440
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