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R Series 10000000001010013

by Zoll Medical Corporation

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

None found

in data synced 23 Oct 2026

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 Number00847946016845 UDI-DI Date19 Sep 2014ListedStatusListed GUDID: in commercial distribution

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 23 Oct 2026.

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Specification

GUDID

Trade Name
R Series
Generic Name
Rechargeable professional automated external defibrillator
Model / Reference
10000000001010013
Description
Defibrillator ,MAIN, MAN-1, PLUS, 3/5 LD, STD ECG, AC PWR, CF/USB, DOMESTIC, REFURB
Primary DI / UDI-DI
00847946016845
FDA Product Code
MKJ
GMDN Term
Rechargeable professional automated external defibrillator
Device Class
Class III
Regulation Number
870.5310
GUDID distribution status
In Commercial Distribution
MRI Safety
MR Unsafe

Related devices

Category: Rechargeable professional automated external defibrillator

Cleared under the same submission (K120907)

Show all (12)

Other devices from Zoll Medical Corporation

See all devices from Zoll Medical Corporation →

Properties

  • Prescription Use
  • Serial Number

Other properties (12)

  • 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
  • Lot / Batch Number: No
  • Expiration Date: No
  • Manufacturing Date: No