FDA.reportPublic FDA data

XLR8 Abdominal Wound Dressing Kit

Primary DI
00849405024101
Brand
XLR8 Abdominal Wound Dressing Kit
Company
GENADYNE BIOTECHNOLOGIES INC.
Model
A4-ABDO1-K
Device description
XLR8 Abdominal wound dressing kit is indicated for use in conjuction with Genadyne NPWT System for patients who have open abdominal wounds with exposed viscera and organs, including but not limited to patients with abdominal compartment syndrome.
Published
2026-03-09
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
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
00849405024101PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00849405024101008494050241018494050241010849405024101

GMDN Terms#

Term, Definition table
TermDefinition
Negative-pressure wound therapy open-abdomen dressingA sterile dressing intended to be used on an open abdominal wall wound, with exposed viscera (e.g., abdominal compartment syndrome), to provide temporary wound bridging during negative-pressure wound therapy when primary closure is not possible and/or repeat abdominal entries are necessary. It typically consists of a nonadherent visceral protective layer, a perforated foam layer, an insulation layer to contain negative pressure, and tubing to connect to a negative-pressure wound therapy unit. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
006616130
Device count
1
Kit
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00849405002796Hybrid Dressing - Revo UnsterileHFD-D1040-UNS2026-03-16
00849405002802Hybrid Dressing - Revo UnsterileHFD-D1050-UNS2026-03-16
00849405002819Hybrid Dressing - Revo UnsterileHFD-D1030-UNS2026-03-16
00849405002826Hybrid Dressing - Revo UnsterileHFD-D1530-UNS2026-03-16
00849405002833Hybrid Dressing - Revo UnsterileHFD-D1520-UNS2026-03-16
00849405002840Hybrid Dressing - Revo UnsterileHFD-D1020-UNS2026-03-16
10849405002793Hybrid Dressing - Revo UnsterileHFD-D1040-UNS2026-03-16
10849405002809Hybrid Dressing - Revo UnsterileHFD-D1050-UNS2026-03-16
10849405002816Hybrid Dressing - Revo UnsterileHFD-D1030-UNS2026-03-16
10849405002823Hybrid Dressing - Revo UnsterileHFD-D1530-UNS2026-03-16
10849405002830Hybrid Dressing - Revo UnsterileHFD-D1520-UNS2026-03-16
10849405002847Hybrid Dressing - Revo UnsterileHFD-D1020-UNS2026-03-16
00849405002581Genadyne DUO NPWTA7-S00012026-03-09
00849405002659XLR8/XLR8+ Port - UnsterileXP-1013-UNSXP-1013-UNS2025-12-03
00849405002666XLR8 Transparent Film DressingA4-S00F5-UNSA4-S00F5-UNS2025-12-03
00849405002673Hybrid Dressing - RevoHFD-D1020HFD-D10202026-01-12
00849405002680Hybrid Dressing - RevoHFD-D1520HFD-D15202026-01-12
00849405002697Hybrid Dressing - RevoHFD-D1030HFD-D10302026-01-12
00849405002703Hybrid Dressing - RevoHFD-D1530HFD-D15302026-01-12
00849405002710Hybrid Dressing - RevoHFD-D1040HFD-D10402026-01-12

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
00197998300912Solventum™ V.A.C.® Granufoam™KCI USA, INC.OMP2026-07-22
00197998300936Solventum™ V.A.C.® Granufoam™KCI USA, INC.OMP2026-07-22
00197998313660Solventum™ V.A.C.® Granufoam™KCI USA, INC.OMP2026-07-22
00197998313691Solventum™ V.A.C.® Granufoam™KCI USA, INC.OMP2026-07-22
00197998313752Solventum™ V.A.C.® Granufoam™KCI USA, INC.OMP2026-07-22
00197998313783Solventum™ V.A.C.® Granufoam™KCI USA, INC.OMP2026-07-22
00197998313844Solventum™ V.A.C.® Granufoam™KCI USA, INC.OMP2026-07-22
00197998313905Solventum™ V.A.C.® Granufoam™KCI USA, INC.OMP2026-07-22
00840117350984Durma+ Flexible Suction Bell, With TubingDynarex CorporationOMP2026-06-22
00197998382819Solventum™ Veraflo™ Cleanse Choice™Solventum US LLCOMP2026-05-28
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00749756392495DeRoyalDEROYAL INDUSTRIES, INC.OMP2026-01-22
08718104890947Endo-SPONGE PumpMeditop B.V.OMP2025-10-17
00197998028922Solventum US LLCKCI USA, INC.OMP2025-07-29
00197998028946Solventum US LLCKCI USA, INC.OMP2025-07-29
00197998032608Solventum US LLCKCI USA, INC.OMP2025-07-29
00197998312267Solventum US LLCKCI USA, INC.OMP2025-07-29