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Mediplus A202Ax-D-M

by Mediplus, Ltd.

Mediplus A202Ax-D-M is a Class II device made by Mediplus, Ltd., cleared under FDA 510(k) K131339 on 25 Nov 2013 and listed in FDA GUDID since 19 Nov 2021 (UDI-DI 05055140704030), active as of 22 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 22 Oct 2026

Documents

510(k) K131339

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number05055140704030 UDI-DI Date19 Nov 2021ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK131339 Date25 Nov 2013DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K131339 decided 25 Nov 2013 Active
  • FDA GUDID UDI-DI 05055140704030 listed 19 Nov 2021 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K131339
  2. Listed FDA GUDID 05055140704030

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Mediplus
Generic name
Capnography oxygen mask
Model / reference
A202Ax-D-M
Primary DI / UDI-DI
05055140704030
510(k) Number
FDA product code
CCK
GMDN term
Capnography oxygen mask
Device class
Class II
Regulation number
868.1400
GUDID distribution status
In Commercial Distribution

Similar devices

Other devices filed under FDA product code CCK (ANALYZER, GAS, CARBON-DIOXIDE, GASEOUS-PHASE).

Other devices from Mediplus, Ltd.

See all devices from Mediplus, Ltd. →

Properties

  • Single use
  • Prescription use
  • Lot / batch number
  • Expiration date
Other properties (11, all answered No)