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HeartBeam ECG System 5002A

by Heartbeam, Inc.

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

None found

in data synced 22 Oct 2026

Documents

None

No authorization documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source GUDID, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00850048674028 UDI-DI Date16 Jul 2026ListedStatusListed GUDID: in commercial distribution

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Specification

GUDID

Trade Name
HeartBeam ECG System
Generic Name
Patient monitoring system module, electrocardiographic, telemetric
Model / Ref / Catalog
5002A
Primary DI / UDI-DI
00850048674028
510(k) Number
FDA Product Code
MWJ, DPS, DXH
GMDN Term
Patient monitoring system module, electrocardiographic, telemetric
Device Class
Class II
Regulation Number
870.2800, 870.2340, 870.2920
GUDID distribution status
In Commercial Distribution
MRI Safety
MR Unsafe

Other devices from Heartbeam, Inc.

Properties

  • Prescription Use
  • Lot / Batch Number
  • Serial Number
  • Expiration Date
  • Manufacturing Date

Other properties (9)

  • Sterile: No
  • Single Use: No
  • Implantable: No
  • Contains Latex: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No