FDA.reportPublic FDA data

PREVENA RESTOR™ BELLA•FORM™

Primary DI
00849554007475
Brand
PREVENA RESTOR™ BELLA•FORM™
Company
KCI USA, INC.
Model
PREVENA RESTOR™ BELLA•FORM™
Device description
PREVENA RESTOR™ BELLA•FORM™ DRESSING – 24CM X 22CM
Published
2019-04-23
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
true
Sterile
true
Single use
true

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00849554007123PackageGS15In Commercial Distribution
00849554007901PackageGS11In Commercial Distribution
00849554007475PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00849554007123008495540071238495540071230849554007123
00849554007901008495540079018495540079010849554007901
00849554007475008495540074758495540074750849554007475

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.

Regulatory Flags#

DUNS number
102726734
Device count
1
Combination product
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00197998301209Solventum™ V.A.C.® Granufoam™M8275053/5 M8275053/10M8275053/5 M8275053/102026-08-07
00197998301285Solventum™ V.A.C.® Granufoam™M8275052/5 M8275052/10M8275052/5 M8275052/102026-08-07
00197998301360Solventum™ V.A.C.® Granufoam™M8275051/5 M8275051/10M8275051/5 M8275051/102026-08-07
00197998301148Solventum™ ActiV.A.C.™M8275058/5 M8275058/10M8275058/5 M8275058/102026-07-23
00197998301162Solventum™ ActiV.A.C.™M8275058/5 M8275058/10M8275058/5 M8275058/102026-07-23
00197998303906Solventum™ ActiV.A.C.™M8275058/5 M8275058/10M8275058/5 M8275058/102026-07-23
00197998276507Solventum™ V.A.C.® Granufoam™M8275065/5M8275065/52026-07-22
00197998300912Solventum™ V.A.C.® Granufoam™M8275053/5 M8275053/10M8275053/5 M8275053/102026-07-22
00197998300936Solventum™ V.A.C.® Granufoam™M8275053/5 M8275053/10M8275053/5 M8275053/102026-07-22
00197998313660Solventum™ V.A.C.® Granufoam™M8275051/5 M8275051/10M8275051/5 M8275051/102026-07-22
00197998313691Solventum™ V.A.C.® Granufoam™M8275051/5 M8275051/10M8275051/5 M8275051/102026-07-22
00197998313752Solventum™ V.A.C.® Granufoam™M8275052/5 M8275052/10M8275052/5 M8275052/102026-07-22
00197998313783Solventum™ V.A.C.® Granufoam™M8275052/5 M8275052/10M8275052/5 M8275052/102026-07-22
00197998313844Solventum™ V.A.C.® Granufoam™M8275065/5 M8275065/10M8275065/5 M8275065/102026-07-22
00197998313905Solventum™ V.A.C.® Granufoam™M8275081/5 M8275081/10M8275081/5 M8275081/102026-07-22
00849554005532SNAP™ STPAL2016-09-24
00849554005549SNAP™ STPALP2016-09-24
00849554005563SNAP™ STPASP2016-09-24
00849554005570SNAP™ STPAMP2016-09-24
00849554005587SNAP™ STPAS2016-09-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
00850084501944Viz™ 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
00850084501050Viz™ Wound DressingNEW HORIZON HEALTHCARE MANAGEMENT LLCOMP2026-07-28
00850084501067Viz™ Wound Visualization Negative Pressure Wound Therapy SystemNEW HORIZON HEALTHCARE MANAGEMENT LLCOMP2026-07-28
00197998301148Solventum™ ActiV.A.C.™KCI USA, INC.OMP2026-07-23
00197998301162Solventum™ ActiV.A.C.™KCI USA, INC.OMP2026-07-23
00197998303906Solventum™ ActiV.A.C.™KCI USA, INC.OMP2026-07-23
00197998276507Solventum™ V.A.C.® Granufoam™KCI USA, INC.OMP2026-07-22