FDA.reportPublic FDA data

Healqu

Primary DI
00819143020925
Brand
Healqu
Company
Healqu LLC
Model
9020905
Device description
HEALQU Transparent Dressing (4 x 5)
Published
2023-11-08
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
00819143021953PackageGS110In Commercial Distribution
00819143022905PackageGS130In Commercial Distribution
00819143025401PackageGS110In Commercial Distribution
00819143025418PackageGS130In Commercial Distribution
00819143025524PackageGS110In Commercial Distribution
00819143025531PackageGS130In Commercial Distribution
00819143025647PackageGS150In Commercial Distribution
00819143025654PackageGS14In Commercial Distribution
00819143026170PackageGS150In Commercial Distribution
00819143026477PackageGS160In Commercial Distribution
00819143026491PackageGS112In Commercial Distribution
10819143020922PackageGS150In Commercial Distribution
20819143020929PackageGS14In Commercial Distribution
00819143020925PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00819143021953008191430219538191430219530819143021953
00819143022905008191430229058191430229050819143022905
00819143025401008191430254018191430254010819143025401
00819143025418008191430254188191430254180819143025418
00819143025524008191430255248191430255240819143025524
00819143025531008191430255318191430255310819143025531
00819143025647008191430256478191430256470819143025647
00819143025654008191430256548191430256540819143025654
00819143026170008191430261708191430261700819143026170
00819143026477008191430264778191430264770819143026477
00819143026491008191430264918191430264910819143026491
1081914302092210819143020922
2081914302092920819143020929
00819143020925008191430209258191430209250819143020925

GMDN Terms#

Term, Definition table
TermDefinition
Synthetic polymer semi-permeable film dressing, adhesiveA transparent, semi-permeable (i.e., impermeable to fluids, permeable to vapours and gases) covering applied to wounded or diseased tissue intended to provide protection (e.g., from dirt, water) and/or promote healing. It is a thin, clear film made of synthetic polymer material that is covered on one side with a pressure-sensitive adhesive. It may be applied directly to tissue or used in combination with other dressings (e.g., gauze) to protect postsurgical incisions and minor wounds (e.g., cuts, scrapes, burns, skin tears, blisters). It may also be used to secure to skin other devices such as vascular catheters, infusion ports, or tubing. This is a single-use device.

Regulatory Flags#

DUNS number
080712881
Device count
1
Premarket exempt
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00819143021335Healqu90241442023-11-09
00819143026347HealquUS-902274112026-03-05
00819143026446HealquUS-902272112026-03-05
00819143026354HealquUS-902274112026-03-05
00819143026453HealquUS-902272112026-03-05
00819143026293HealquUS-90227411-22026-02-19
00819143026309HealquUS-90227411-22026-02-19
00819143021052Healqu9022944-302023-11-08
00819143021342Healqu90241662023-11-09
00819143021366Healqu90242442023-11-09
00819143020888Healqu90209012023-11-08
00819143021359Healqu90242222023-11-09
00819143025241HealquUS-90227211-22025-07-10
00819143025340HealquUS-902276112025-08-21
00819143025685HealquCA-90227211-22025-08-21
00819143025722HealquCA-902274112025-08-21
00819143025746HealquCA-902276112025-08-21
00819143025357HealquUS-902276112025-08-21
00819143025692HealquCA-90227211-22025-08-21
00819143025739HealquCA-902274112025-08-21

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10840330701607ProCureTwin Med, LLCNAD2026-04-28
10840330701614ProCureTwin Med, LLCNAD2026-04-28
10840330701621ProCureTwin Med, LLCNAD2026-04-28
10840330701638ProCureTwin Med, LLCNAD2026-04-28
10840330701645ProCureTwin Med, LLCNAD2026-04-28
10840330701652ProCureTwin Med, LLCNAD2026-04-28
10840330701669ProCureTwin Med, LLCNAD2026-04-28
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10192253038866KendallCardinal Health 200, LLCNAD2025-11-21
10197344169559MEDLINEMEDLINE INDUSTRIES, INC.NAD2025-11-14
10197344162512MEDLINEMEDLINE INDUSTRIES, INC.NAD2025-11-07
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10197344162543MEDLINEMEDLINE INDUSTRIES, INC.NAD2025-10-17
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