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Intraosseous Infusion Needles G05312

by Ecs Opco 1 LLC

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

None found

in data synced 23 Oct 2026

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 Number00840464800019 UDI-DI Date27 May 2026ListedStatusListed GUDID: in commercial distribution

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 23 Oct 2026.

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Specification

GUDID

Trade Name
Intraosseous Infusion Needles
Generic Name
Intraosseous infusion kit
Model / Ref / Catalog
G05312, C-DIN-14-3.0-T45-DKM
Primary DI / UDI-DI
00840464800019
510(k) Number
FDA Product Code
FMI
GMDN Term
Intraosseous infusion kit
Device Class
Class II
Regulation Number
880.5570
GUDID distribution status
In Commercial Distribution

Related devices

Cleared under the same submission (K250724)

Other devices from Ecs Opco 1 LLC

Properties

  • Sterile
  • Single Use
  • Prescription Use
  • Lot / Batch Number
  • Expiration Date
  • Manufacturing Date

Other properties (8)

  • Implantable: No
  • Contains Latex: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No