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Control-Cric 313-4567

by Pulmodyne Inc.

Ref 313-4567

Control-Cric 313-4567 is a device classified as Class IIa in the EU and Class II in the US made by Pulmodyne Inc., registered in EUDAMED on 29 Oct 2026 (Basic UDI-DI B-00841470109066), cleared under FDA 510(k) K830509 on 29 Mar 1983 and listed in FDA GUDID since 30 Sep 2021 (UDI-DI 00841470109066), active as of 7 Nov 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 7 Nov 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K830509

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 7 Nov 2026.

Regulatory status

as of registry sync 7 Nov 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-00841470109066 Basic UDI-DI 00841470109066UDI-DIDate29 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00841470109066 UDI-DI Date30 Sep 2021ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK830509 Date29 Mar 1983DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI B-00841470109066 registered 29 Oct 2026 Active
  • FDA 510(k) K830509 decided 29 Mar 1983 Active
  • FDA GUDID UDI-DI 00841470109066 listed 30 Sep 2021 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K830509
  2. Listed FDA GUDID 00841470109066
  3. Registered EUDAMED B-00841470109066

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  • Withdrawn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
Control Cric EUDAMED
Control-Cric GUDID
Generic name
Cricothyrotomy kit, single-use
Device name
Control Cric System
Model / reference
313-4567
Primary DI / UDI-DI
00841470109066
Basic UDI-DI
B-00841470109066
510(k) Number
FDA product code
BTO
EMDN code
R01058099 Tracheostomy and laryngectomy cannulas - various accessories
GMDN term
Cricothyrotomy kit, single-use
Device class
Class IIa EUDAMED
Class II GUDID
Regulation number
868.5800
EU registration type
Legacy device (under a directive)
EU market of registration
Denmark
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
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: Cricothyrotomy kit, single-use

Similar devices in this category

Other devices filed under TRACHEOSTOMY AND LARYNGECTOMY CANNULAS - VARIOUS ACCESSORIES.

Other devices from Pulmodyne Inc.

See all devices from Pulmodyne Inc. →

Properties

  • Supplied sterile
  • Single use
  • Prescription use
  • Lot / batch number
  • Expiration date
Other properties (18, all answered No)