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i.Series® PC4200i

by HELMER Inc.

i.Series® PC4200i is a Class II device made by HELMER Inc., listed in FDA GUDID since 1 Jul 2016 (UDI-DI 00816394020780), 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 Number00816394020780 UDI-DI Date1 Jul 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  • Withdrawn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

Trade name
i.Series®
Generic name
Platelet incubator
Model / reference
PC4200i
Primary DI / UDI-DI
00816394020780
FDA product code
KSH
GMDN term
Platelet incubator
Device class
Class II
Regulation number
864.9575
GUDID distribution status
In Commercial Distribution

Related devices

Category: Platelet incubator

Other devices from HELMER Inc.

See all devices from HELMER Inc. →

Properties

  • Premarket exempt
  • Serial number
  • Manufacturing date
Other properties (12, all answered No)