FDA.reportPublic FDA data

BD ChloraShield™ IV Dressing with CHG Antimicrobial

Primary DI
50885403284760
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
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
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, antimicrobial, sterileA sterile 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

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
370514887
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
true
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#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10885403284762BD ChloraShield™ IV Dressing with CHG Antimicrobial4101112019-04-15
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
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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