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Shiley 4.0NEF

by Covidien LP

Ref 4.0NEF

Shiley 4.0NEF is a device classified as Class IIb in the EU and Class II in the US made by Covidien LP, registered in EUDAMED on 17 Aug 2026 (Basic UDI-DI 0763000B000100875), cleared under FDA 510(k) K182861 on 22 Mar 2019 (1 earlier submission) and listed in FDA GUDID since 4 May 2019 (UDI-DI 20884521779614), active as of 24 Oct 2026. One FDA recall is linked to it.

Active European Union and United States. Also listed in GUDID (US).

CE MDR 510(k)

Valid until

No date given

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

None ongoing

1 closed

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K182861

+1 more

Trust

Unverified

Source EUDAMED, GUDID, synced 24 Oct 2026.

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number0763000B000100875 Basic UDI-DI 20884521779614UDI-DIDate17 Aug 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number20884521779614 UDI-DI Date4 May 2019ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK182861 Date22 Mar 2019DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 0763000B000100875 registered 17 Aug 2026 Active
  • FDA 510(k) K182861 decided 22 Mar 2019 Active· +1 more in the status table
  • FDA GUDID UDI-DI 20884521779614 listed 4 May 2019 Listed

Recalls

1 recall · FDA

    • Terminated Z-1951-2015 FDA Class I initiated 8 May 2015

    Reports where patients who recently switched from the current Shiley Neonatal and Pediatric products to the affected products experienced discomfort and in some cases, breathing difficulties, corresponding to a negative effect on oxygen levels.

Timeline

5 dated events

  1. Cleared FDA 510(k) K122531
  2. Recall initiated FDA recalls Z-1951-2015
  3. Cleared FDA 510(k) K182861
  4. Listed FDA GUDID 20884521779614
  5. Registered EUDAMED 0763000B000100875

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States FDA 510(k) Active

Specification

EUDAMED · GUDID

Trade name
Shiley
Generic name
Tracheostomy tube, non-reinforced, non-customized, single-use
Device name
Shiley Neonatal TT Cuffless
Model / reference
4.0NEF
Primary DI / UDI-DI
20884521779614
Basic UDI-DI
0763000B000100875
510(k) Number
FDA product code
JOH
EMDN code
R0105010101 Tracheostomic cannulas, cuffless, not reinforced, with fixed flange, and kits
GMDN term
Tracheostomy tube, non-reinforced, non-customized, single-use
Device class
Class IIb EUDAMED
Class II GUDID
Regulation number
868.5800
EU registration type
Standard device
EU market of registration
Netherlands
GUDID distribution status
In Commercial Distribution
MRI safety
MR Safe
Size
Length — 34 Millimeter
Angle — 120 degree

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device classEUDAMED
Class IIb
GUDID
Class II

Device class is stated on each registry's own scale: Class IIb in the EU (EUDAMED), Class II in the US (FDA GUDID). EU and US classes are different schemes, so this is not a disagreement.

Related devices

Category: Tracheostomy tube, non-reinforced, non-customized, single-use

Cleared under the same submission (K122531)

and 8 more cleared under K122531

Cleared under the same submission (K182861)

and 8 more cleared under K182861

Similar devices in this category

Other devices filed under INTUBATION DEVICES.

Other devices from Covidien LP

  • LigaSure MRASILF19

    Class II

  • Shiley 110860

    Class II

  • Shiley 110865

    Class II

  • Shiley 110870

    Class II

See all devices from Covidien LP →

Properties

  • Supplied sterile
  • Single use
  • Prescription use
  • Lot / batch number
  • Expiration date
Other properties (20, all answered No)