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Microstream DLPM35MN02-RR

by Covidien LP

Microstream DLPM35MN02-RR is a Class II device made by Covidien LP, cleared under FDA 510(k) K200594 on 27 Apr 2020 and listed in FDA GUDID since 27 May 2022 (UDI-DI 10884521761261), 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) K200594

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 Number10884521761261 UDI-DI Date27 May 2022ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK200594 Date27 Apr 2020DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K200594 decided 27 Apr 2020 Active
  • FDA GUDID UDI-DI 10884521761261 listed 27 May 2022 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K200594
  2. Listed FDA GUDID 10884521761261

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Microstream
Generic name
Carbon dioxide monitor
Model / reference
DLPM35MN02-RR
Primary DI / UDI-DI
10884521761261
510(k) Number
FDA product code
CCK
GMDN term
Carbon dioxide monitor
Device class
Class II
Regulation number
868.1400
GUDID distribution status
In Commercial Distribution
MRI safety
MR Safe

Similar devices

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

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See all devices from Covidien LP →

Properties

  • Prescription use
  • Serial number
  • Manufacturing date
Other properties (12, all answered No)