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X Series 620-2121001-01

by Zoll Medical Corporation

Listed FDA GUDID listing, not in commercial distribution

Valid until

Not applicable

Database listing, no authorization

FDA recalls

None ongoing

2 closed

Documents

None

No authorization documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source GUDID, synced 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00847946023614 UDI-DI Date12 Oct 2017ListedStatusListed GUDID: not in commercial distribution

Recalls

2 recalls · FDA

    • Terminated Z-1311-2014 FDA Class II initiated 5 Mar 2014

    Defibrillator/Pacemaker/Monitor May Latch in a Continuous Device Reset Loop and cannot be used

    • Terminated Z-2401-2012 FDA Class II initiated 16 Aug 2012

    Shipped with incorrect software

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Specification

GUDID

Trade Name
X Series
Generic Name
Physiologic-monitoring defibrillation system
Model / Reference
620-2121001-01
Primary DI / UDI-DI
00847946023614
FDA Product Code
DQA, DSK, DXN, DRT, CCK, LDD, DRO, LIX, MKJ
GMDN Term
Physiologic-monitoring defibrillation system
Device Class
Class II
Regulation Number
870.2700, 870.1110, 870.1130, 870.2300, 868.1400, 870.5300, 870.5550, 870.5210, 870.5310
GUDID distribution status
Not in Commercial Distribution

Related devices

Cleared under the same submission (K112432)

Show all (12)

Other devices from Zoll Medical Corporation

See all devices from Zoll Medical Corporation →

Properties

  • Serial Number

Other properties (13)

  • Sterile: No
  • Single Use: No
  • Implantable: No
  • Contains Latex: No
  • Prescription Use: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Lot / Batch Number: No
  • Expiration Date: No
  • Manufacturing Date: No