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El-Spike-M

by Neodevices Inc

El-Spike-M is a Class II device made by Neodevices Inc, listed in FDA GUDID since 1 Jun 2026 (UDI-DI 00816340021632), registry data as of 22 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 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00816340021632 UDI-DI Date1 Jun 2026ListedStatusListed 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  • Withdrawn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

Generic name
Oral/enteral syringe drawing-up straw
Model / reference
EL-SPIKE-M
Description
Cross spike adapter w/purple male locking connector. EnFit™ compatible. Set Length 4.5" Approx Priming Volume 0.5ml
Primary DI / UDI-DI
00816340021632
FDA product code
KNT
GMDN term
Oral/enteral syringe drawing-up straw
Device class
Class II
Regulation number
876.5980
GUDID distribution status
In Commercial Distribution

Similar devices

Other devices filed under FDA product code KNT (Tubes, Gastrointestinal (And Accessories)).

Other devices from Neodevices Inc

See all devices from Neodevices Inc →

Properties

  • Single use
  • Prescription use
  • Lot / batch number
Other properties (12, all answered No)