FDA.reportPublic FDA data

PREVENA PLUS™ PEEL & PLACE™

Primary DI
00849554006621
Brand
PREVENA PLUS™ PEEL & PLACE™
Company
KCI USA, INC.
Model
PRE3201US
Device description
Prevena Plus Peel & Place System Kit- 35 cm
Published
2017-11-17
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K153199000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K153199000Prevena Plus Incision Management System Kit with Peel & Place Dressing, Prevena Plus Peel & Place Dressing 5-Pack, Prevena Plus Incision Management System Kit with Customizable Dressing, Prevena Plus Customizable Dressing 5-PackKci USA, Inc.2016-02-29OMP

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00849554006621PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00849554006621008495540066218495540066210849554006621

GMDN Terms#

Term, Definition table
TermDefinition
Negative-pressure wound therapy system, battery-powered, 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 a non-sterile battery-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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

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

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
00197998028939Solventum US LLCABT1055ABT10552025-07-29
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
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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