FDA.reportPublic FDA data

Tracoe Purofoam-T Large Lite

Primary DI
05060031485462
Brand
Tracoe Purofoam-T Large Lite
Company
BRIGHTWAKE LIMITED
Model
CR4556
Device description
Non-Adhesive Tracheostomy Dressing
Published
2025-10-08
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
NACDressing, Wound, Hydrophilic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NACDressing, Wound, HydrophilicGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05060031485462PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05060031485462050600314854625060031485462

GMDN Terms#

Term, Definition table
TermDefinition
Tracheostomy tube dressingA 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.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Height0.25Centimeter
Length8Centimeter
Width8Centimeter

Contacts#

Phone, Email table
PhoneEmail
+441623751151info@brightwake.co.uk

Regulatory Flags#

DUNS number
226502201
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
05060031485424Tracoe Purofoam-T LargeCR45552025-10-08
05060031485509Tracoe Purofoam-T SmallCR45572025-10-08
05060031482645Eclypse Non-BackedCR45172025-08-07
05060031482683Eclypse Non-BackedCR45182025-08-07
05060031482720Eclypse Non-BackedCR45192025-08-07
05060031484724Activon Manuka Honey Barrier CreamCR45462025-08-07
05060031482652Eclypse Non-BackedCR45172025-08-07
05060031482690Eclypse Non-BackedCR45182025-08-07
05060031482737Eclypse Non-BackedCR45192025-08-07
05060031484748Activon Manuka Honey Barrier CreamCR45462025-08-07
05060031485349Activon Manuka Honey Barrier CreamCR45522025-08-07
05060031482607Eclypse Non-BackedCR45162025-08-05
05060031474145Activon TulleCR41362023-07-27
05060031474107Activon TulleCR41352024-01-18
05060031479676Eclypse ContourCR43982023-07-27
05060031471182Activon TubeCR38302023-07-27
05060031482003Activon TubeCR44932023-07-27
05060031475708Advazorb Border CR41952024-01-17
05060031475715Advazorb Border CR41952024-01-17
05060031470901EclypseCR37692023-07-27

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
09551031940007DODODOTSDODO VENTURES SDN. BHD.NAC2026-04-22
09551031940014DODODOTSDODO VENTURES SDN. BHD.NAC2026-04-22
09551031940021DODODOTSDODO VENTURES SDN. BHD.NAC2026-04-22
09551031940038DODODOTSDODO VENTURES SDN. BHD.NAC2026-04-22
09551031940045DODODOTSDODO VENTURES SDN. BHD.NAC2026-04-22
09551031940052DODODOTSDODO VENTURES SDN. BHD.NAC2026-04-22
09551031940069DODODOTSDODO VENTURES SDN. BHD.NAC2026-04-22
09551031940076DODODOTSDODO VENTURES SDN. BHD.NAC2026-04-22
09551031940083DODODOTSDODO VENTURES SDN. BHD.NAC2026-04-22
09551031940090DODODOTSDODO VENTURES SDN. BHD.NAC2026-04-22
09551031940106DODODOTSDODO VENTURES SDN. BHD.NAC2026-04-22
09551031940113DODODOTSDODO VENTURES SDN. BHD.NAC2026-04-22
09551031940120DODODOTSDODO VENTURES SDN. BHD.NAC2026-04-22
09551031940137DODODOTSDODO VENTURES SDN. BHD.NAC2026-04-22
09551031940144DODODOTSDODO VENTURES SDN. BHD.NAC2026-04-22
09551031940151DODODOTSDODO VENTURES SDN. BHD.NAC2026-04-22
09551031940168DODODOTSDODO VENTURES SDN. BHD.NAC2026-04-22
09551031940175DODODOTSDODO VENTURES SDN. BHD.NAC2026-04-22
09551031940182DODODOTSDODO VENTURES SDN. BHD.NAC2026-04-22
09551031940199DODODOTSDODO VENTURES SDN. BHD.NAC2026-04-22
09551031940205DODODOTSDODO VENTURES SDN. BHD.NAC2026-04-22
09551031940212DODODOTSDODO VENTURES SDN. BHD.NAC2026-04-22
09551031940229DODODOTSDODO VENTURES SDN. BHD.NAC2026-04-22
09551031940236DODODOTSDODO VENTURES SDN. BHD.NAC2026-04-22
09551031940243DODODOTSDODO VENTURES SDN. BHD.NAC2026-04-22
09551031940250DODODOTSDODO VENTURES SDN. BHD.NAC2026-04-22
09551031940267DODODOTSDODO VENTURES SDN. BHD.NAC2026-04-22
09551031940274DODODOTSDODO VENTURES SDN. BHD.NAC2026-04-22
09551031940281DODODOTSDODO VENTURES SDN. BHD.NAC2026-04-22
09551031940298DODODOTSDODO VENTURES SDN. BHD.NAC2026-04-22