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Viz™ Wound Visualization Negative Pressure Wound Therapy System Viz™ NPWT Pump Kit

by New Horizon Healthcare Management LLC

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

None found

in data synced 22 Oct 2026

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 Number00850084501074 UDI-DI Date24 Aug 2026ListedStatusListed GUDID: in commercial distribution

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

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  • Withdrawn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 / Reference
Viz™ NPWT Pump Kit
Primary DI / UDI-DI
00850084501074
510(k) Number
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

Related devices

Cleared under the same submission (K212359)

Show all (9)

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