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Ventlab 4714

by Ventlab Corp.

Ventlab 4714 is a Class II device made by Ventlab Corp., cleared under FDA 510(k) K063813 on 26 Mar 2008 and listed in FDA GUDID since 26 Sep 2016 (UDI-DI 10889483071564), active as of 23 Oct 2026.

Active United States. Also listed in GUDID (US).

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 23 Oct 2026

Documents

510(k) K063813

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number10889483071564 UDI-DI Date26 Sep 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK063813 Date26 Mar 2008DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K063813 decided 26 Mar 2008 Active
  • FDA GUDID UDI-DI 10889483071564 listed 26 Sep 2016 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K063813
  2. Listed FDA GUDID 10889483071564

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Ventlab
Generic name
Exhaled-gas oesophageal intubation detector
Model / reference
4714
Primary DI / UDI-DI
10889483071564
FDA product code
CCK
GMDN term
Exhaled-gas oesophageal intubation detector
Device class
Class II
Regulation number
868.1400
GUDID distribution status
In Commercial Distribution
Size
Length — 14 Feet

Related devices

Category: Exhaled-gas oesophageal intubation detector

Cleared under the same submission (K063813)

and 8 more cleared under K063813

Similar devices

Other devices filed under FDA product code CCK (Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase).

Other devices from Ventlab Corp.

See all devices from Ventlab Corp. →

Properties

  • Single use
  • Prescription use
  • Lot / batch number
  • Expiration date
  • Manufacturing date
Other properties (10, all answered No)