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510(k) Data Aggregation
K Number
K202208Device Name
BeneHold Surgical Incise Drape with CHG antimicrobial
Manufacturer
Avery Dennison Belgie BVBA
Date Cleared
2021-07-30
(358 days)
Product Code
KKX
Regulation Number
878.4370Why did this record match?
Applicant Name (Manufacturer) :
Avery Dennison Belgie BVBA
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The BeneHold™ Surgical Incise Drape with CHG is indicated for use as an incise drape with continuous antibacterial activity (in vitro) from 2.5 to 4 hours against the following organisms; S. epidermidis, E. faecalis, E. coli, P. aeruginosa and E. aerogenes.
It is intended for external use only. Correlation between in vitro results and any clinical event has not been tested.
Device Description
Not Found
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K Number
K170407Device Name
BD ChloraShield IV Dressing with CHG Antimicrobial
Manufacturer
Avery Dennison Belgie BVBA
Date Cleared
2017-07-17
(157 days)
Product Code
FRO
Regulation Number
N/AWhy did this record match?
Applicant Name (Manufacturer) :
Avery Dennison Belgie BVBA
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The BD ChloraShield IV Dressing with CHG antimicrobial is intended to cover and protect catheter sites and to secure devices to the skin. Common applications include securing IV catheters, other intravascular catheters and percutaneous devices.
Device Description
The BD ChloraShield™ IV Dressing with CHG antimicrobial consists of a transparent adhesive dressing integrated with Chlorhexidine Gluconate (CHG), a well known antiseptic agent with broad-spectrum antimicrobial activity, which serves as a preservative within the dressing.
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K Number
K152923Device Name
BD ChloraShield IV Dressing with CHG Antimicrobial
Manufacturer
AVERY DENNISON BELGIE BVBA
Date Cleared
2015-11-05
(31 days)
Product Code
FRO
Regulation Number
N/AWhy did this record match?
Applicant Name (Manufacturer) :
AVERY DENNISON BELGIE BVBA
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The BD ChloraShield IV Dressing with CHG antimicrobial, per K152923, is intended to cover and protect catheter sites and to secure devices to the skin. Common applications include securing IV catheters, other intravascular catheters and percutaneous devices.
Device Description
The BD ChloraShield IV Dressing with CHG antimicrobial consists of a transparent adhesive dressing with integrated Chlorhexidine Gluconate (CHG), a well known antiseptic agent with broad-spectrum antimicrobial activity, which serves as a preservative within the dressing.
Ask a Question
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