FDA.reportPublic FDA data

Solventum US LLC

Primary DI
00197998028939
Brand
Solventum US LLC
Company
KCI USA, INC.
Model
ABT1055
Catalog number
ABT1055
Device description
Solventum™ AbThera™ Advance Open Abdomen Dressing Kit, ABT1055, 5/CS
Published
2025-07-29
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00197998028939PackageGS15In Commercial Distribution
00197998028922PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00197998028939001979980289391979980289390197998028939
00197998028922001979980289221979980289220197998028922

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

Contacts#

Phone, Email table
PhoneEmail
+1(800)228-3957regulatoryrequests@solventum.com

Regulatory Flags#

DUNS number
102726734
Device count
1
DM exempt
true
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
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
00849554005532SNAP™ STPAL2016-09-24
00849554005549SNAP™ STPALP2016-09-24
00849554005563SNAP™ STPASP2016-09-24
00849554005570SNAP™ STPAMP2016-09-24
00849554005587SNAP™ STPAS2016-09-24
108495540138623M™ V.A.C.®EZ5SMLV001 / EZ5SMLV002EZ5SML2024-03-05
108495540138793M™ V.A.C.®EZ5MEDV001 / EZ5MEDV002EZ5MED2024-03-05
108495540138863M™ V.A.C.®EZ5LRGV001 / EZ5LRGV002EZ5LRG2024-03-05
008495540080143M™ Prevena Restor™ Adaptiform™PRE6001PRE60012022-08-18
008495540083733M™ Prevena Restor™ Adaptiform™PRE6055PRE60552022-08-18
00197998028922Solventum US LLCABT1055ABT10552025-07-29
00197998028946Solventum US LLCABT1055ABT10552025-07-29
00197998032608Solventum US LLCM8275026/5M8275026/52025-07-29
00197998312267Solventum US LLCM8275026/5M8275026/52025-07-29
00197998028953Solventum US LLCABT1055ABT10552025-07-29
00197998032615Solventum US LLCM8275026/5M8275026/52025-07-29
00197998312274Solventum US LLCM8275026/5M8275026/52025-07-29
00197998028809Solventum US LLCSTPASSTPAS2025-07-23
00197998028816Solventum US LLCSTPAMPSTPAMP2025-07-23
00197998028823Solventum US LLCSTPAMSTPAM2025-07-23

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00197998382819Solventum™ Veraflo™ Cleanse Choice™Solventum US LLCOMP2026-05-28
00197998382895Solventum™ Veraflo™ Cleanse Choice™Solventum US LLCOMP2026-05-28
00849405002796Hybrid Dressing - Revo UnsterileGENADYNE BIOTECHNOLOGIES INC.OMP2026-03-16
00849405002802Hybrid Dressing - Revo UnsterileGENADYNE BIOTECHNOLOGIES INC.OMP2026-03-16
00849405002819Hybrid Dressing - Revo UnsterileGENADYNE BIOTECHNOLOGIES INC.OMP2026-03-16
00849405002826Hybrid Dressing - Revo UnsterileGENADYNE BIOTECHNOLOGIES INC.OMP2026-03-16
00849405002833Hybrid Dressing - Revo UnsterileGENADYNE BIOTECHNOLOGIES INC.OMP2026-03-16
00849405002840Hybrid Dressing - Revo UnsterileGENADYNE BIOTECHNOLOGIES INC.OMP2026-03-16
00749756392495DeRoyalDEROYAL INDUSTRIES, INC.OMP2026-01-22
00849405002673Hybrid Dressing - RevoGENADYNE BIOTECHNOLOGIES INC.OMP2026-01-12
00849405002680Hybrid Dressing - RevoGENADYNE BIOTECHNOLOGIES INC.OMP2026-01-12
00849405002697Hybrid Dressing - RevoGENADYNE BIOTECHNOLOGIES INC.OMP2026-01-12
00849405002703Hybrid Dressing - RevoGENADYNE BIOTECHNOLOGIES INC.OMP2026-01-12
00849405002710Hybrid Dressing - RevoGENADYNE BIOTECHNOLOGIES INC.OMP2026-01-12
00849405002727Hybrid Dressing - RevoGENADYNE BIOTECHNOLOGIES INC.OMP2026-01-12
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
10851978007662WoundPro+ Collection CanisterPensar Medical, LLCOMP2025-03-18
10851978007679WoundPro+ 300cc Advanced Canister w/8' TubingPensar Medical, LLCOMP2025-03-18
10851978007631WoundPro+ 300cc Advanced Canister w/5' TubingPensar Medical, LLCOMP2025-01-14
07612367016940Invia Liberty Carrying CaseMedela AGOMP2024-10-11
07612367060509Invia Motion Carrying CaseMedela AGOMP2024-10-11
07612367038713Standard rail universal holderMedela AGOMP2024-06-03
00749756390194DeRoyalDEROYAL INDUSTRIES, INC.OMP2024-05-08
00749756390200DeRoyalDEROYAL INDUSTRIES, INC.OMP2024-05-08
00749756390217DeRoyalDEROYAL INDUSTRIES, INC.OMP2024-05-08
108495540138623M™ V.A.C.®KCI USA, INC.OMP2024-03-05