FDA.report

V.A.C. ATS™

Primary DI
00878237000830
Brand
V.A.C. ATS™
Company
KCI USA, INC.
Model
M6275071/5 M6275071/10
Device description
500 ml canister for VAC ATS Therapy Systems
Published
2016-09-05
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
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
00878237001066PackageGS110Not in Commercial Distribution
00878237001349PackageGS15Not in Commercial Distribution
00878237000830PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00878237001066008782370010668782370010660878237001066
00878237001349008782370013498782370013490878237001349
00878237000830008782370008308782370008300878237000830

GMDN Terms

TermDefinition
Negative-pressure wound therapy system canisterA receptacle for the collection of excess interstitial fluid, exudate, and infectious materials from a dedicated dressing that has been applied for a vacuum-assisted wound closure procedure; commonly known as negative pressure wound therapy (NPWT). It is typically made of transparent disposable plastic materials and is connected to or placed into the NPWT system's vacuum pump. This receptacle is a single-use device that should be discarded, including its contaminated waste content, according to the environmental legislation by which the user is bound (e.g., incineration, recycling, landfill).

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

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