Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3007648359

FEI Number

3007648359

Entity Name

BRIGHTWAKE LTD

City/State/Country

Kirkby-in-Ashfield Nottinghamshire, GB

Establishment Address

Lowmoor Business Park, Kirkby-in-Ashfield Nottinghamshire NG17 7JZ, GB

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Brightwake Ltd (Owner Number: 10029414)

Owner / Operator Contact Address

Sidings Road, Lowmoor Business Park, Nottingham, GB-NTT NG17 7JZ, GB

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K101118

PMA Number

N/A

All Registered Proprietary Names

Tracheostomy Tube Holder with brush AVELLE Negative Pressure Wound Therapy System Tracoe Purofoam-T Lite Eclypse Super Absorbent Dressing Advazorb Hydrophilic Foam Dressing Eclypse Border Eclypse Sacral Adherent Super Absorbent Dressing Eclypse Border Oval Adherent Super Absorbent Dressing Advazorb Sacral Hydrophilic Foam Dressing Eclypse Adherent Sacral Super Absorbent Dressing Eclypse Adherent Super Absorbent Dressing Advazorb Silfix Hydrophilic Foam Dressing Advazorb Silfix Lite Hydrophilic Foam Dressing Advazorb Border Lite Hydrophilic Foam Dressing Eclypse Boot Super Absorbent Dressing Advazorb Lite Hydrophilic Foam Dressing Advazorb Heel Hydrophilic Foam Dressing Eclypse Foot Super Absorbent Dressing Advazorb Border Hydrophilic Foam Dressing Eclypse Contour Super Absorbent Dressing Advazorb Fixation Advazorb Areola Tracoe Purofoam-T Small Post-Decannulation Dressing Eclypse Non-Backed Tracoe Purofoam-T Large Voice Prosthesis Brush Silflex soft silicone wound contact dressing Vellafilm soft silicone wound contact dressing Activon Tube 100 percent Medical Grade Manuka Honey with No Preservatives Siltape Soft silicone perforated tape Advasil Conform Silicone gel sheet Surepress Unna-Flex Elastic Unna boot Unna boot Stretch Zinc 4 x 10yrd Unna boot Stretch Zinc + Calamine 3 x 10yrd Unna boot Non-stretch Zinc + Calamine 3 x 10yrd Unna boot Non-stretch Zinc 4 x 10yrd Unna-Z Stretch Zinc + Calamine 3 x 10yrd Unna boot Stretch Zinc 3 x 10yrd Unna-Z Non-stretch Zinc 4 x 10yrd Unna-Z Stretch Zinc 4 x 10yrd Unna-Z Non-stretch Zinc 3 x 10yrd Unna-Z Non-stretch Zinc + Calamine 4 x 10yrd Unna boot Non-stretch Zinc + Calamine 4 x 10yrd Unna-Z Stretch Zinc + Calamine 4 x 10yrd Unna boot Stretch Zinc + Calamine 4 x 10yrd Unna-Z Stretch Zinc 3 x 10yrd Unna boot Non-stretch Zinc 3 x 10yrd Unna-Z Non-stretch Zinc + Calamine 3 x 10yrd Activon Manuka Honey Barrier Cream AQUACEL Ag Burn Activon Tulle

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
JAY	Support, Breathing Tube	Anesthesiology	Class 1	868.5280	2013-05-20
OMP	Negative Pressure Wound Therapy Powered Suction Pump	General, Plastic Surgery	Class 2	878.4780	2018-11-16
NAC	Dressing, Wound, Hydrophilic	General, Plastic Surgery	Class 1	878.4018	2010-01-19
EPE	Brush, Cleaning, Tracheal Tube	Anesthesiology	Class 1	868.5795	2020-08-21
NAD	Dressing, Wound, Occlusive	General, Plastic Surgery	Class 1	878.4020	2012-06-15
FRO	Dressing, Wound, Drug	Unknown	Class U	N/A	2014-09-17
KGX	Tape And Bandage, Adhesive	General Hospital	Class 1	880.5240	2012-06-15
MDA	Elastomer, Silicone, For Scar Management	General, Plastic Surgery	Class 1	878.4025	2012-06-15
FQM	Bandage, Elastic	General Hospital	Class 1	880.5075	2010-01-19
NEC	Bandage, Liquid, Skin Protectant	General Hospital	Class 1	880.5090	2025-08-05
FRO	Dressing, Wound, Drug	Unknown	Class U	N/A	2010-02-08
FRO	Dressing, Wound, Drug	Unknown	Class U	N/A	2011-03-16

Official Correspondent

Edwin Lindsay

US Agent Details

John Cody Business: Medi USA LP Email: johnc@mediusa.com Phone: (336) 4494440

Related Public Records

Same Entity

Brightwake Ltd

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K881936	Iberhospitex, S.A.	OPER-FILM-ADHESIVE MEMBRANE	1988-08-31
K150256	Argentum Medical	SILVERLON BURN CONTACT DRESSINGS	2015-04-30
K843874	Beiersdorf, Inc.	LEUKOPOR SURGICAL TAPE	1985-02-21
K915446	Sun Glitz Corp.	STRETCH WRAP	1992-05-06
K833120	Acme United Corp.	ONE TIME COMPOUND BENZOIN TINCTURE-	1983-12-29

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0009-2013	Accuro Medical Product LLC	2	Wound Pro Apex Negative Pressure Wound Therapy Powered Suction Pump; Accuro Medical Products LLC, 2854 Hitchcock Ave, Downers Grove, IL 60515; part number 84635400182, sold inside the Apex Negative Wound Therapy system, part number 84635400181 Promotes wound healing through drainage and removal of infectious material and other fluids from the wound site using continuous and/or intermittent negative pressure. Types of wounds indicated include diabetic/neuropathic ulcers, pressure ulcers, chronic wounds, acute wounds and dehisced wounds.
Z-0039-2015	Smith & Nephew, Inc.	2	RENASYS EZ/ RENASYS EZ Plus 250 mL canister with Solidifier Product Usage: RENASYS EZ and RENASYS EZ Plus Canisters are used for the collection of exudate removed from wounds being treated by negative pressure wound therapy (NPWT).
Z-0040-2015	Smith & Nephew, Inc.	2	RENASYS EZ/ RENASYS EZ Plus 800 mL canister with Solidifier Product Usage: RENASYS EZ and RENASYS EZ Plus Canisters are used for the collection of exudate removed from wounds being treated by negative pressure wound therapy (NPWT).
Z-0041-2015	Smith & Nephew, Inc.	2	RENASYS EZ/ RENASYS EZ Plus 800 mL canister (w/o CLP) with Solidifier Product Usage: RENASYS EZ and RENASYS EZ Plus Canisters are used for the collection of exudate removed from wounds being treated by negative pressure wound therapy (NPWT).
Z-0013-2019	COVIDIEN LLC	1	Kerlix AMD Antimicrobial Bandage Roll, 6 Ply, 4-1/2 x 12.3 (11.4 cm x 3.7m), REF 3332 Product Usage- as both primary and secondary dressing containing PHMB (polyhexamethylene biguanide) to resist bacterial colonization within the dressing and bacterial penetration through the dressing.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3007648359. Last updated year: 2026. Please use registration number 3007648359 when referencing this establishment in official correspondence.