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Viz™ Wound Visualization Negative Pressure Wound Therapy System proEWS

by New Horizon Healthcare Management LLC

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 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00850084501005 UDI-DI Date28 Jul 2026ListedStatusListed 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  • Withdrawn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
Viz™ Wound Visualization Negative Pressure Wound Therapy System
Generic Name
Negative-pressure wound therapy system, electric, single-use
Model / Ref / Catalog
proEWS, 100797NH
Primary DI / UDI-DI
00850084501005
FDA Product Code
OMP
GMDN Term
Negative-pressure wound therapy system, electric, single-use
Device Class
Class II
Regulation Number
878.4780
GUDID distribution status
In Commercial Distribution
MRI Safety
MR Unsafe

Other devices from New Horizon Healthcare Management LLC

See all devices from New Horizon Healthcare Management LLC →

Properties

  • Single Use
  • Prescription Use
  • Lot / Batch Number
  • Expiration Date
  • Manufacturing Date

Other properties (9)

  • Sterile: 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