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Innovision 00

by Innovere Medical, Inc.

Innovision 00 is a Class I device made by Innovere Medical, Inc., listed in FDA GUDID since 22 Feb 2021 (UDI-DI 00628176432229), registry data as of 23 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 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00628176432229 UDI-DI Date22 Feb 2021ListedStatusListed 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  • Withdrawn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
Innovision
Generic name
Patient audiovisual communication/entertainment system
Model / reference
00
Primary DI / UDI-DI
00628176432229
FDA product code
OUG
GMDN term
Patient audiovisual communication/entertainment system
Device class
Class I
Regulation number
880.6310
GUDID distribution status
In Commercial Distribution
MRI safety
MR Conditional

Related devices

Category: Patient audiovisual communication/entertainment system

Similar devices

Other devices filed under FDA product code OUG (Medical Device Data System).

Other devices from Innovere Medical, Inc.

  • Innovision 00

    Class II

  • Innovision Audio

    Class II

Properties

  • Prescription use
  • Convenience kit
  • Premarket exempt
  • Lot / batch number
  • Serial number
  • Manufacturing date
Other properties (9, all answered No)