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Blood pressure cuff for SURDIAL DX Hemodialysis System HXA-GCUFF-XLRA

by Nipro Medical Corporation

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

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 Number00383790012409 UDI-DI Date19 Dec 2025ListedStatusListed GUDID: in commercial distribution

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Specification

GUDID

Trade Name
Blood pressure cuff for SURDIAL DX Hemodialysis System
Generic Name
Blood pressure cuff, reusable
Model / Reference
HXA-GCUFF-XLRA
Primary DI / UDI-DI
00383790012409
FDA Product Code
KDI
GMDN Term
Blood pressure cuff, reusable
Device Class
Class II
Regulation Number
876.5860
GUDID distribution status
In Commercial Distribution

Other devices from Nipro Medical Corporation

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Properties

  • Prescription Use
  • Lot / Batch 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
  • Serial Number: No
  • Expiration Date: No
  • Manufacturing Date: No