Solventum US LLC M8275026/5

GUDID 00197998312274

Solventum™ AbThera™ SensaT.R.A.C.™ Open Abdomen Dressing Kit, M8275026/5, 5/PAC

KCI USA, INC.

Negative-pressure wound therapy open-abdomen dressing
Primary Device ID00197998312274
NIH Device Record Keye07b0faa-8f22-43ae-a10f-986a1642a2c8
Commercial Distribution StatusIn Commercial Distribution
Brand NameSolventum US LLC
Version Model NumberM8275026/5
Catalog NumberM8275026/5
Company DUNS102726734
Company NameKCI USA, INC.
Device Count1
DM Exempttrue
Pre-market Exemptfalse
MRI Safety StatusMR Conditional
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(800)228-3957
Emailregulatoryrequests@solventum.com
Phone+1(800)228-3957
Emailregulatoryrequests@solventum.com
Phone+1(800)228-3957
Emailregulatoryrequests@solventum.com
Phone+1(800)228-3957
Emailregulatoryrequests@solventum.com
Phone+1(800)228-3957
Emailregulatoryrequests@solventum.com
Phone+1(800)228-3957
Emailregulatoryrequests@solventum.com
Phone+1(800)228-3957
Emailregulatoryrequests@solventum.com
Phone+1(800)228-3957
Emailregulatoryrequests@solventum.com
Phone+1(800)228-3957
Emailregulatoryrequests@solventum.com
Phone+1(800)228-3957
Emailregulatoryrequests@solventum.com
Phone+1(800)228-3957
Emailregulatoryrequests@solventum.com
Phone+1(800)228-3957
Emailregulatoryrequests@solventum.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100197998312267 [Primary]
GS100197998312274 [Package]
Contains: 00197998312267
Package: CASE [5 Units]
In Commercial Distribution

FDA Product Code

OMPnegative pressure wound therapy Powered suction pump

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2025-08-06
Device Publish Date2025-07-29

On-Brand Devices [Solventum US LLC]

00197998028915Solventum™ Snap™ Plus Therapy Strap, STPALP, Large, 1/CS
00197998028908Solventum™ Snap™ Plus Therapy Strap, STPASP, Small, 1/CS
00197998028892Solventum™ Snap™ Therapy Strap, STPAL, Large, 1/CS
00197998028885Solventum™ Snap™ Plus Therapy Strap, STPASPEE, Small, 1/CS
00197998028878Solventum™ Snap™ Therapy Strap, STPASEE, Small, 1/CS
00197998028861Solventum™ Snap™ Plus Therapy Strap, STPAMPEE, Medium, 1/CS
00197998028854Solventum™ Snap™ Therapy Strap, STPAMEE, Medium, 1/CS
00197998028847Solventum™ Snap™ Plus Therapy Strap, STPALPEE, Large, 1/CS
00197998028830Solventum™ Snap™ Therapy Strap, STPALEE, Large, 1/CS
00197998028823Solventum™ Snap™ Therapy Strap, STPAM, Medium, 1/CS
00197998028816Solventum™ Snap™ Plus Therapy Strap, STPAMP, Medium, 1/CS
00197998028809Solventum™ Snap™ Therapy Strap, STPAS, Small, 1/CS
00197998312274Solventum™ AbThera™ SensaT.R.A.C.™ Open Abdomen Dressing Kit, M8275026/5, 5/PAC
00197998032615Solventum™ AbThera™ SensaT.R.A.C.™ Open Abdomen Dressing Kit, M8275026/5, 5/PAC
00197998028953Solventum™ AbThera™ Advance Open Abdomen Dressing Kit, ABT1055, 5/CS
00197998028939Solventum™ AbThera™ Advance Open Abdomen Dressing Kit, ABT1055, 5/CS
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