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Defibtech ARM XR Extended Suction Cup (package of 1) RPP-2005

by Defibtech, L.L.C.

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

1 ongoing

Recall on shared 510(k) K211289; other models may be affected

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 Number00815098021475 UDI-DI Date26 Jun 2026ListedStatusListed GUDID: in commercial distribution

Recalls

1 recall · 1 ongoing · FDA

    • Ongoing Z-2543-2024 FDA Class I initiated 12 Jul 2024 on shared 510(k) K211289

    Problem in the device's motor may cause the device to stop compressions. This may lead to a delay in therapy if the device fails to operate, and could lead to patient injury or death.

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Specification

GUDID

Trade Name
Defibtech ARM XR Extended Suction Cup (package of 1)
Generic Name
Cardiac resuscitator, battery-powered
Model / Reference
RPP-2005
Primary DI / UDI-DI
00815098021475
510(k) Number
FDA Product Code
MKJ
GMDN Term
Cardiac resuscitator, battery-powered
Device Class
Class III
Regulation Number
870.5310
GUDID distribution status
In Commercial Distribution

Related devices

Cleared under the same submission (K211289)

Other devices from Defibtech, L.L.C.

See all devices from Defibtech, L.L.C. →

Properties

  • Single Use
  • Lot / Batch Number

Other properties (12)

  • Sterile: 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
  • Serial Number: No
  • Expiration Date: No
  • Manufacturing Date: No