FDA.reportPublic FDA data

Viz™ Wound Visualization Negative Pressure Wound Therapy System

Primary DI
00850084501944
Brand
Viz™ Wound Visualization Negative Pressure Wound Therapy System
Company
NEW HORIZON HEALTHCARE MANAGEMENT LLC
Model
HM3081
Device description
1' x 3' Oblong Viz Wound Dressing, Viz Negative Pressure Wound Therapy Pump, Viz Wound Exudate Canister and Batteries. Suitable for use in both hospital and homecare. setting. Includes an extra 50 ml replacement canister for collecting wound exudate.
Published
2026-09-24
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true
OTC
false
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
OMPNegative Pressure Wound Therapy Powered Suction Pump

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OMPNegative Pressure Wound Therapy Powered Suction PumpGeneral, Plastic Surgery2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K212359000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K212359000PWD Negative Pressure Wound Therapy SystemApplied Tissue Technologies, LLC2022-09-21OMP

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850084501944PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850084501944008500845019448500845019440850084501944

GMDN Terms#

Term, Definition table
TermDefinition
Negative-pressure wound therapy system, electric, single-useA portable assembly of devices designed to apply suction to help heal traumatic and chronic skin wounds (e.g., grafts, incisions, burns, ulcers) with low to moderate levels of exudate. It typically consists of an electrically-powered vacuum pump, a highly-absorbent wound dressing and/or collection canister to contain the exudate, and a connection tube. The pump applies continuous or intermittent negative pressure to the wound via the tube/dressing to decompress capillaries/lymphatic vessels, improve blood/interstitial fluid circulation, draw wound edges together, facilitate granulation tissue formation, and prepare the wound bed for closure. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Humidity00
Handling Environment Temperature00
Special Storage Condition, Specify00Store in a Dry Place
Storage Environment Temperature00

Contacts#

Phone, Email table
PhoneEmail
1-883-564-6467customerservice@nhmedical.com

Regulatory Flags#

DUNS number
125920651
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850084501920Viz™ Wound Visualization Negative Pressure Wound Therapy SystemHM30702026-09-24
00850084501937Viz™ Wound Visualization Negative Pressure Wound Therapy SystemHM30762026-09-24
00850084501951Viz™ Wound Visualization Negative Pressure Wound Therapy SystemHM30862026-09-24
00850084501036Viz™ Wound Dressing3" Round2026-07-28
00850084501005Viz™ Wound Visualization Negative Pressure Wound Therapy SystemproEWS100797NH2026-07-28
00850084501012Xpansion® Micro-Autografting KitNHMS2026-07-28
00850084501029Viz™ Wound Dressing2" Round2026-07-28
00850084501043Viz™ Wound Dressing1" x 3" Oblong2026-07-28
00850084501050Viz™ Wound Dressing3" x 5" Oblong2026-07-28
00850084501067Viz™ Wound Visualization Negative Pressure Wound Therapy SystemCanister100799NH2026-07-28

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00749756402316DeRoyalDEROYAL INDUSTRIES, INC.OMP2026-10-16
00749756402323DeRoyalDEROYAL INDUSTRIES, INC.OMP2026-10-16
00749756402330DeRoyalDEROYAL INDUSTRIES, INC.OMP2026-10-16
00749756402347DeRoyalDEROYAL INDUSTRIES, INC.OMP2026-10-16
00749756402354DeRoyalDEROYAL INDUSTRIES, INC.OMP2026-10-16
00749756402361DeRoyalDEROYAL INDUSTRIES, INC.OMP2026-10-16
00749756402378DeRoyalDEROYAL INDUSTRIES, INC.OMP2026-10-16
00850084501920Viz™ Wound Visualization Negative Pressure Wound Therapy SystemNEW HORIZON HEALTHCARE MANAGEMENT LLCOMP2026-09-24
00850084501937Viz™ Wound Visualization Negative Pressure Wound Therapy SystemNEW HORIZON HEALTHCARE MANAGEMENT LLCOMP2026-09-24
00850084501951Viz™ Wound Visualization Negative Pressure Wound Therapy SystemNEW HORIZON HEALTHCARE MANAGEMENT LLCOMP2026-09-24
00749756369640DeRoyalDEROYAL INDUSTRIES, INC.OMP2026-09-23
00749756985475DeRoyalDEROYAL INDUSTRIES, INC.OMP2026-09-21
00749756985963DeRoyalDEROYAL INDUSTRIES, INC.OMP2026-09-21
00749756985994DeRoyalDEROYAL INDUSTRIES, INC.OMP2026-09-21
00749756986250DeRoyalDEROYAL INDUSTRIES, INC.OMP2026-09-21
00749756401289DeRoyalDEROYAL INDUSTRIES, INC.OMP2026-09-18
00749756401692DeRoyalDEROYAL INDUSTRIES, INC.OMP2026-09-18
00749756401746DeRoyalDEROYAL INDUSTRIES, INC.OMP2026-09-18
04719873697724NACARILEX MEDICAL, INC.OMP2026-08-26
04719873697731NACARILEX MEDICAL, INC.OMP2026-08-26
04719873697748NACARILEX MEDICAL, INC.OMP2026-08-26
04719873697755NACARILEX MEDICAL, INC.OMP2026-08-26
04719873697762NACARILEX MEDICAL, INC.OMP2026-08-26
00197998301209Solventum™ V.A.C.® Granufoam™KCI USA, INC.OMP2026-08-07
00197998301285Solventum™ V.A.C.® Granufoam™KCI USA, INC.OMP2026-08-07
00197998301360Solventum™ V.A.C.® Granufoam™KCI USA, INC.OMP2026-08-07
00850084501005Viz™ Wound Visualization Negative Pressure Wound Therapy SystemNEW HORIZON HEALTHCARE MANAGEMENT LLCOMP2026-07-28
00850084501029Viz™ Wound DressingNEW HORIZON HEALTHCARE MANAGEMENT LLCOMP2026-07-28
00850084501036Viz™ Wound DressingNEW HORIZON HEALTHCARE MANAGEMENT LLCOMP2026-07-28
00850084501043Viz™ Wound DressingNEW HORIZON HEALTHCARE MANAGEMENT LLCOMP2026-07-28