FDA.report

DermaBlue + Foam Transfer

Primary DI
00714196764485
Brand
DermaBlue + Foam Transfer
Company
DERMARITE INDUSTRIES LLC
Model
76040418
Catalog number
76040418
Device description
ANTIMICROBIAL FOAM WOUND DRESSING WITH METHYLENE BLUE, GENTIAN VIOLET, AND SILVER
Published
2020-01-27
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
true
Sterile
true
Single use
true

Related Records

Product Codes

CodeName
FRODressing, Wound, Drug

Product Code Classifications

CodeDeviceSpecialtyClass
FRODressing, Wound, DrugUnknownU

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00714196764485PrimaryGS10
1714196764484Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00714196764485007141967644857141967644850714196764485
1714196764484017141967644841714196764484

GMDN Terms

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.

Sterilization Methods

Method

Regulatory Flags

DUNS number
883925562
Device count
10
DM exempt
false
Premarket exempt
true
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
true
Sterilization required before use
false

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00714196390189Bordered Foam00298E2021-09-09
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00714196390301Sterile Bordered Gauze113642021-09-09
00714196390325Sterile Bordered Gauze114102021-09-09

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