FDA.reportPublic FDA data

BD ChloraShield™ IV Dressing with CHG Antimicrobial

Primary DI
10885403284762
Brand
BD ChloraShield™ IV Dressing with CHG Antimicrobial
Company
Avery Dennison Belgie BVBA
Model
410111
Device description
BD ChloraShield™ IV Dressing with Chlorhexidine Gluconate (CHG) Antimicrobial, 3.0 x 2.4 in (75 x 60 mm)
Published
2019-04-15
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
FRODressing, Wound, Drug

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FRODressing, Wound, DrugUnknownU

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20885403284769PackageGS1100In Commercial Distribution
50885403284760PackageGS110In Commercial Distribution
10885403284762PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2088540328476920885403284769
5088540328476050885403284760
1088540328476210885403284762

GMDN Terms#

Term, Definition table
TermDefinition
Exudate-absorbent dressing, non-gel, antimicrobialA wound covering intended to absorb exudates and blood from a wound (e.g., ulcers, burns, surgical wounds, lacerations, abrasions, and/or percutaneous device wounds), and that contains an antimicrobial agent [e.g., silver (Ag), chlorhexidine gluconate (CHG)]. It is not in the form of a gel and does not produce a water-absorbent gel upon contact with wound exudate. It is intended to create a moist wound-healing environment and/or protect wounds from external contamination by microorganisms from the periwound skin. The device may be in the form of a flat sheet/film, ribbon, rope, foam, liquid, or powder. After application, this device cannot be reused.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature0 Degrees Fahrenheit77 Degrees Fahrenheit

Regulatory Flags#

DUNS number
370514887
Device count
1
Combination product
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10885403284779BD ChloraShield™ IV Surround Dressing with CHG Antimicrobial4101222019-04-15
10885403288876BD ChloraShield™ IV Dressing with CHG Antimicrobial4101312019-04-15
10885403288883BD ChloraShield™ IV Surround Dressing with CHG Antimicrobial4101322019-04-15
10885403430022BD ChloraShield™ IV Nexiva™ Dressing with CHG Antimicrobial4101232019-04-15
50885403284760BD ChloraShield™ IV Dressing with CHG Antimicrobial4101112019-04-15
50885403284777BD ChloraShield™ IV Surround Dressing with CHG Antimicrobial4101222019-04-15
50885403288874BD ChloraShield™ IV Dressing with CHG Antimicrobial4101312019-04-15
50885403288881BD ChloraShield™ IV Surround Dressing with CHG Antimicrobial4101322019-04-15
50885403430020BD ChloraShield™ IV Nexiva™ Dressing with CHG Antimicrobial4101232019-04-15

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