FDA.reportPublic FDA data

DermaFoam Tracheostomy

Primary DI
00714196453303
Brand
DermaFoam Tracheostomy
Company
Sion Brands LLC
Model
45330
Published
2020-09-01
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
NADDressing, Wound, Occlusive

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NADDressing, Wound, OcclusiveGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00714196453303PrimaryGS10
01714196453302Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00714196453303007141964533037141964533030714196453303
01714196453302017141964533021714196453302

GMDN Terms#

Term, Definition table
TermDefinition
Tracheostomy tube dressing, sterileA sterile foam pad designed to conform around a tracheostomy tube at its insertion site to provide protection for the skin and/or to absorb secretions. It is typically designed with a slit or hole to facilitate tube fitting. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
118753405
Device count
10
Premarket exempt
true
Lot or batch
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00714196003317DermaCol 100 Gel 1oz Tube0033112026-06-01
00714196111050DermaRite Medical DermaHoney Medical Grade Honey 0.5 oz Tube111052026-06-01
00714196111074DermaRite Medical DermaHoney Medical Grade Honey 1.75 oz Tube111072026-06-01
01714196112452DermaRite Medical Wound Gel- Amorphous Hydrogel112452026-06-01
01714196222045DermaRite Medical DermaHoney Tulle Non Border Honey Gauze 4x4222042026-06-01
01714196333048DermaRite Medical DermaHoney Border Medical Grade Honey Sheet 4x4333042026-06-01
08717249680130DermaRite Medical L-Mesitran 0.5 oz Tube20301US2026-06-01
08717249680147DermaRite Medical L-Mesitran 1.75 oz Tube20501US2026-06-01
00714196112453DermaSyn112452020-09-01
00714196930712Bordered Foam Healogics by DermaRite930712020-09-01
00714196930736Bordered Foam Healogics by DermaRite930732020-09-01
01714196422629ComfortGauze Border422622025-01-08
01714196422636ComfortGauze Border422632025-01-08
07141964645074AquaRite Ag Extra CMC464502025-06-01
07141964666000AquaRite Ag Extra CMC466602025-06-01
71419624712486DermaSyn002472024-10-21
01714196500150SilvaKollagen Gel00500005002023-10-04
00714196390028AquaDerm00322E2022-05-02
00714196391780DermaFilm thin with Border00229E2021-09-10
00714196390004Adhesive Tape Remover Pads821002021-09-09

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Primary DI, Brand, Company table
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