ABTHERA ADVANCE™

GUDID 00849554006966

ABTHERA ADVANCE™ OPEN ABDOMEN DRESSING

KCI USA, INC.

Negative-pressure wound therapy open-abdomen dressing
Primary Device ID00849554006966
NIH Device Record Key2ebf31ed-71d0-4e5c-b121-6aa143835214
Commercial Distribution StatusIn Commercial Distribution
Brand NameABTHERA ADVANCE™
Version Model NumberABT1055
Company DUNS102726734
Company NameKCI USA, INC.
Device Count1
DM Exemptfalse
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

Device Identifiers

Device Issuing AgencyDevice ID
GS100849554006942 [Package]
Package: 5 PACK [5 Units]
In Commercial Distribution
GS100849554006966 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

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 Date2018-08-06
Device Publish Date2018-07-04

Devices Manufactured by KCI USA, INC.

00197998028939 - Solventum US LLC2025-08-06 Solventum™ AbThera™ Advance Open Abdomen Dressing Kit, ABT1055, 5/CS
00197998028953 - Solventum US LLC2025-08-06 Solventum™ AbThera™ Advance Open Abdomen Dressing Kit, ABT1055, 5/CS
00197998032615 - Solventum US LLC2025-08-06 Solventum™ AbThera™ SensaT.R.A.C.™ Open Abdomen Dressing Kit, M8275026/5, 5/PAC
00197998312274 - Solventum US LLC2025-08-06 Solventum™ AbThera™ SensaT.R.A.C.™ Open Abdomen Dressing Kit, M8275026/5, 5/PAC
00197998028809 - Solventum US LLC2025-07-31 Solventum™ Snap™ Therapy Strap, STPAS, Small, 1/CS
00197998028816 - Solventum US LLC2025-07-31 Solventum™ Snap™ Plus Therapy Strap, STPAMP, Medium, 1/CS
00197998028823 - Solventum US LLC2025-07-31 Solventum™ Snap™ Therapy Strap, STPAM, Medium, 1/CS
00197998028830 - Solventum US LLC2025-07-31 Solventum™ Snap™ Therapy Strap, STPALEE, Large, 1/CS
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