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Infinity Trident NMT SmartPod 7876910

by Draeger Medical Systems, Inc.

Ref 7876910Model 007139

Infinity Trident NMT SmartPod 7876910 is a medical device (EU MDD Class IIb; FDA Class II; FDA product code KOI, Stimulator, Nerve, Peripheral, Electric; EMDN category vital signs monitoring instruments - hardware accessories) made by Draeger Medical Systems, Inc., registered in EUDAMED on 27 May 2026 (Basic UDI-DI B-04049098007139), cleared under FDA 510(k) K042003 on 1 Sep 2004 and listed in FDA GUDID since 24 Oct 2015 (UDI-DI 04049098007139), active as of 23 Oct 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 23 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K042003

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-04049098007139 Basic UDI-DI 04049098007139UDI-DIDate27 May 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number04049098007139 UDI-DI Date24 Oct 2015ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK042003 Date1 Sep 2004DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI B-04049098007139 registered 27 May 2026 Active
  • FDA 510(k) K042003 decided 1 Sep 2004 Active
  • FDA GUDID UDI-DI 04049098007139 listed 24 Oct 2015 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K042003
  2. Listed FDA GUDID 04049098007139
  3. Registered EUDAMED B-04049098007139

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  • Withdrawn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
Infinity Trident NMT SmartPod
Generic name
Block-monitoring peripheral nerve electrical stimulation system
Model / reference
7876910, 007139
Primary DI / UDI-DI
04049098007139
Basic UDI-DI
B-04049098007139
510(k) Number
FDA product code
KOI
EMDN code
Z12030280 Vital signs monitoring instruments - hardware accessories
GMDN term
Block-monitoring peripheral nerve electrical stimulation system
Device class
Class IIb EUDAMED
Class II GUDID
Regulation number
868.2775
EU registration type
Legacy device (under a directive)
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device classEUDAMED
Class IIb
GUDID
Class II

Device class is stated on each registry's own scale: Class IIb 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: Block-monitoring peripheral nerve electrical stimulation system

Cleared under the same submission (K042003)

Similar devices in this category

Other devices filed under VITAL SIGNS MONITORING INSTRUMENTS - HARDWARE ACCESSORIES.

Other devices from Draeger Medical Systems, Inc.

See all devices from Draeger Medical Systems, Inc. →

Properties

  • Measuring function
  • Serial number
  • Manufacturing date
Other properties (22, all answered No)