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Nebulizing Elbow Entrainment Elbow Nebulizing Elbow Kit

by Respironics Inc.

Ref 1119028

Nebulizing Elbow Entrainment Elbow Nebulizing Elbow Kit (1119028) is a device classified as Class IIa in the EU and Class II in the US made by Respironics Inc., registered in EUDAMED on 22 Jul 2026 (Basic UDI-DI B-00606959007833), cleared under FDA 510(k) K102240 on 10 Nov 2010 and listed in FDA GUDID since 18 Sep 2016 (UDI-DI 00606959007833), active as of 24 Oct 2026.

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

CE MDD 510(k)

Valid until

No date given

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

FDA recalls

None found

in data synced 24 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K102240

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 24 Oct 2026.

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-00606959007833 Basic UDI-DI 00606959007833UDI-DIDate22 Jul 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00606959007833 UDI-DI Date18 Sep 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Special NumberK102240 Date10 Nov 2010DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI B-00606959007833 registered 22 Jul 2026 Active
  • FDA 510(k) K102240 decided 10 Nov 2010 Active
  • FDA GUDID UDI-DI 00606959007833 listed 18 Sep 2016 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K102240
  2. Listed FDA GUDID 00606959007833
  3. Registered EUDAMED B-00606959007833

Coverage

2 jurisdictions

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  • Withdrawn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

Specification

EUDAMED · GUDID

Trade name
Entrainment Elbow Nebulizing Elbow Kit EUDAMED
Nebulizing Elbow GUDID
Generic name
CPAP/BPAP face mask, single-use
Model / Ref / Catalog
1119028, Entrainment Elbow Nebulizing Elbow Kit
Primary DI / UDI-DI
00606959007833
Basic UDI-DI
B-00606959007833
510(k) Number
FDA product code
CAF
EMDN code
R03010199 Ventilation masks - other
GMDN term
CPAP/BPAP face mask, single-use
Device class
Class IIa EUDAMED
Class II GUDID
Regulation number
868.5630
EU registration type
Legacy device (under a directive)
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / referenceEUDAMED
1119028
GUDID
Entrainment Elbow Nebulizing Elbow Kit
Device classEUDAMED
Class IIa
GUDID
Class II

Device class is stated on each registry's own scale: Class IIa 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: CPAP/BPAP face mask, single-use

Cleared under the same submission (K102240)

and 3 more cleared under K102240

Similar devices in this category

Other devices filed under VENTILATION MASKS - OTHER.

Other devices from Respironics Inc.

See all devices from Respironics Inc. →

Properties

  • Single use
  • Prescription use
  • Lot / batch number
Other properties (22, all answered No)