FDA.reportPublic FDA data

Healqu

Primary DI
10819143020618
Brand
Healqu
Company
Healqu LLC
Model
9020666
Device description
Healqu Bordered Silicone Foam Dressing Lite 6in x 6in
Published
2023-11-30
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
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
10819143020618PackageGS110In Commercial Distribution
20819143020615PackageGS110In Commercial Distribution
00819143020611PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1081914302061810819143020618
2081914302061520819143020615
00819143020611008191430206118191430206110819143020611

GMDN Terms#

Term, Definition table
TermDefinition
Wound-nonadherent dressing, absorbent, non-antimicrobialA wound covering typically in the form of a multi-layered pad having a material or substance on its skin-contact surface (e.g., silicone gel), or designed to be soaked in saline prior to application, to prevent adherence to the wound bed thereby decreasing wound trauma potential; it does not contain an antimicrobial agent. It is typically used to absorb wound blood/exudates while protecting the wound from external contamination and maintaining a moist internal environment. It may be used as a primary or secondary dressing to treat chronic and postoperative wounds, burns, ulcers, abrasions, cuts, or puncture sites; it is not a dedicated burn dressing. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
080712881
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
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00819143020888Healqu90209012023-11-08
00819143020918Healqu90209152023-11-09
00819143021373Healqu90242662023-11-09
00819143025241HealquUS-90227211-22025-07-10
00819143026347HealquUS-902274112026-03-05
00819143021052Healqu9022944-302023-11-08
00819143021069Healqu9022966-302023-11-08
00819143020925Healqu90209052023-11-08
00819143026446HealquUS-902272112026-03-05
00819143021335Healqu90241442023-11-09
00819143026354HealquUS-902274112026-03-05
00819143026453HealquUS-902272112026-03-05
00819143026293HealquUS-90227411-22026-02-19
00819143026309HealquUS-90227411-22026-02-19
00819143021342Healqu90241662023-11-09
00819143021366Healqu90242442023-11-09
00819143021359Healqu90242222023-11-09
00819143025340HealquUS-902276112025-08-21
00819143025685HealquCA-90227211-22025-08-21
00819143025722HealquCA-902274112025-08-21

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00749756399258DeRoyalDEROYAL INDUSTRIES, INC.NAD2026-09-21
07333350341596Mepitel®Mölnlycke Health Care ABNAD2026-09-21
05701780265058Biatain AdhesiveColoplast A/SNAD2026-08-27
04719873697779NACARILEX MEDICAL, INC.NAD2026-08-26
04719873697786NACARILEX MEDICAL, INC.NAD2026-08-26
04719873697793NACARILEX MEDICAL, INC.NAD2026-08-26
04719873697809NACARILEX MEDICAL, INC.NAD2026-08-26
04719873697816NACARILEX MEDICAL, INC.NAD2026-08-26
04719873697823NACARILEX MEDICAL, INC.NAD2026-08-26
00850088144925CARBOUNingbo kehu Medical Technology Co.,Ltd.NAD2026-08-14
040640351931573M™ Tegaderm™3M Deutschland GmbHNAD2026-07-24
040640351931953M™ Tegaderm™3M Deutschland GmbHNAD2026-07-24
040640351932323M™ Tegaderm™3M Deutschland GmbHNAD2026-07-24
05060483573083Russell Chest Seal - Twin (US Version)SAFEGUARD MEDICAL TECHNOLOGIES LIMITEDNAD2026-07-24
05060483570006Russell Chest Seal (US Version)SAFEGUARD MEDICAL TECHNOLOGIES LIMITEDNAD2026-07-20
00850088144642CARBOUNingbo kehu Medical Technology Co.,Ltd.NAD2026-07-10
00850088144659CARBOUNingbo kehu Medical Technology Co.,Ltd.NAD2026-07-10
00850088144697CARBOUNingbo kehu Medical Technology Co.,Ltd.NAD2026-07-10
00850088144215CARBOUNingbo kehu Medical Technology Co.,Ltd.NAD2026-07-08
00850088144222CARBOUNingbo kehu Medical Technology Co.,Ltd.NAD2026-07-08
00850088144239CARBOUNingbo kehu Medical Technology Co.,Ltd.NAD2026-07-08
00850088144246CARBOUNingbo kehu Medical Technology Co.,Ltd.NAD2026-07-08
00850088144253CARBOUNingbo kehu Medical Technology Co.,Ltd.NAD2026-07-08
00850088144000CARBOUNingbo kehu Medical Technology Co.,Ltd.NAD2026-07-03
00850088144017CARBOUNingbo kehu Medical Technology Co.,Ltd.NAD2026-07-03
00850087488686CeeportCEEPORT INC.NAD2026-06-30
06970206823946Dr Perfect Hydrocolloid DressingJiangsu NewValue Medical Products Co.,Ltd.NAD2026-06-22
06970206823977kegel Hydrocolloid DressingJiangsu NewValue Medical Products Co.,Ltd.NAD2026-06-22
06970206827067Ourmed Foam DressingJiangsu NewValue Medical Products Co.,Ltd.NAD2026-06-22
06970206827074Ourmed Foam DressingJiangsu NewValue Medical Products Co.,Ltd.NAD2026-06-22