FDA.report

PREVENA™ CUSTOMIZABLE™

Primary DI
00849554000056
Brand
PREVENA™ CUSTOMIZABLE™
Company
KCI USA, INC.
Model
PRE2001US
Device description
Prevena Incision Management System- Customizable Dressing
Published
2016-09-05
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true
OTC
false
Sterile
false
Single use
true

Related Records

Product Codes

CodeName
OMPNegative Pressure Wound Therapy Powered Suction Pump

Product Code Classifications

CodeDeviceSpecialtyClass
OMPNegative Pressure Wound Therapy Powered Suction PumpGeneral, Plastic Surgery2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00849554000056PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00849554000056008495540000568495540000560849554000056

GMDN Terms

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

Regulatory Flags

DUNS number
102726734
Device count
1
DM exempt
false
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

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00197998028892Solventum US LLCSTPALSTPAL2025-07-23
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