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Medline DYNJAA11

by Medline Industries, Inc.

Medline DYNJAA11 is a gas sampling line filter (FDA Class II; FDA product code CCK, Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase) made by Medline Industries, Inc., cleared under FDA 510(k) K946044 on 27 Dec 1994 and listed in FDA GUDID since 14 Oct 2016 (UDI-DI 10884389129180), 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) K946044

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 Number10884389129180 UDI-DI Date14 Oct 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK946044 Date27 Dec 1994DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K946044 decided 27 Dec 1994 Active
  • FDA GUDID UDI-DI 10884389129180 listed 14 Oct 2016 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K946044
  2. Listed FDA GUDID 10884389129180

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Medline
Generic name
Gas sampling line filter, single-use
Model / Ref / Catalog
DYNJAA11
Primary DI / UDI-DI
10884389129180
510(k) Number
FDA product code
CCK
GMDN term
Gas sampling line filter, single-use
Device class
Class II
Regulation number
868.1400
GUDID distribution status
In Commercial Distribution

Related devices

Category: Gas sampling line filter, single-use

Cleared under the same submission (K946044)

and 8 more cleared under K946044

Similar devices

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

Other devices from Medline Industries, Inc.

See all devices from Medline Industries, Inc. →

Properties

  • Single use
  • Prescription use
  • Lot / batch number
Other properties (12, all answered No)