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Pu-621R

by Nihon Kohden America, Inc.

Pu-621R (PU-621RA) is a Class II device made by Nihon Kohden America, Inc., listed in FDA GUDID since 19 Sep 2016 (UDI-DI 00841983101083), registry data as of 22 Oct 2026.

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

Source GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00841983101083 UDI-DI Date19 Sep 2016ListedStatusListed GUDID: in commercial distribution

Official records

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Specification

GUDID

Generic name
Centralized patient monitor
Model / Ref / Catalog
PU-621R, PU-621RA
Primary DI / UDI-DI
00841983101083
FDA product code
MHX
GMDN term
Centralized patient monitor
Device class
Class II
Regulation number
870.1025
GUDID distribution status
In Commercial Distribution
MRI safety
MR Unsafe

Related devices

Category: Centralized patient monitor

Other devices from Nihon Kohden America, Inc.

See all devices from Nihon Kohden America, Inc. →

Properties

  • Prescription use
  • Serial number
Other properties (13, all answered No)