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CardioLabs RX93030-002

by Datrix LLC

CardioLabs RX93030-002 is a Class II device made by Datrix LLC, listed in FDA GUDID since 10 Feb 2017 (UDI-DI 00851074007187), registry data as of 22 Oct 2026.

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None

No authorization documents

Trust

Unverified

Source GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00851074007187 UDI-DI Date10 Feb 2017ListedStatusListed GUDID: in commercial distribution

Official records

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Specification

GUDID

Trade name
CardioLabs
Generic name
Telemetric electrocardiographic ambulatory recorder
Model / reference
RX93030-002
Primary DI / UDI-DI
00851074007187
FDA product code
MWJ
GMDN term
Telemetric electrocardiographic ambulatory recorder
Device class
Class II
Regulation number
870.2800
GUDID distribution status
In Commercial Distribution

Related devices

Category: Telemetric electrocardiographic ambulatory recorder

Similar devices

Other devices filed under FDA product code MWJ (Electrocardiograph,Ambulatory(Without Analysis)).

Other devices from Datrix LLC

See all devices from Datrix LLC →

Properties

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