FDA.report

DermaBlue + Foam

Primary DI
01714196764446
Brand
DermaBlue + Foam
Company
DERMARITE INDUSTRIES LLC
Model
76040414
Catalog number
76040414
Device description
ANTIMICROBIAL FOAM WOUND DRESSING WITH METHYLENE BLUE, GENTIAN VIOLET, AND SILVER
Published
2021-04-14
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
01714196764446PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
01714196764446017141967644461714196764446

GMDN Terms

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.

Sterilization Methods

Method

Regulatory Flags

DUNS number
883925562
Device count
1
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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00714196052629ComfortGauze Border422622025-01-08
00714196052636ComfortGauze Border422632025-01-08
71419624712486DermaSyn002472024-10-21
01714196500150SilvaKollagen Gel00500005002023-10-04
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00714196390080AquaRite Extra CMC40318403182021-09-09
00714196390103AquaRite Extra CMC404502021-09-09
00714196390127AquaRite Extra CMC406602021-09-09
00714196390141Bordered Foam 4" Round00288E2021-09-09
00714196390165Bordered Foam00297E2021-09-09
00714196390189Bordered Foam00298E2021-09-09
00714196390288Sterile Bordered Gauze112302021-09-09
00714196390301Sterile Bordered Gauze113642021-09-09
00714196390325Sterile Bordered Gauze114102021-09-09

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