FDA.reportPublic FDA data

Healqu

Primary DI
00819143020918
Brand
Healqu
Company
Healqu LLC
Model
9020915
Device description
Healqu Transparent Dressing 8 x12
Published
2023-11-09
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
00819143025289PackageGS110In Commercial Distribution
00819143025296PackageGS110In Commercial Distribution
00819143025708PackageGS110In Commercial Distribution
00819143025715PackageGS110In Commercial Distribution
10819143020915PackageGS110In Commercial Distribution
20819143020912PackageGS110In Commercial Distribution
00819143020918PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00819143025289008191430252898191430252890819143025289
00819143025296008191430252968191430252960819143025296
00819143025708008191430257088191430257080819143025708
00819143025715008191430257158191430257150819143025715
1081914302091510819143020915
2081914302091220819143020912
00819143020918008191430209188191430209180819143020918

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
00819143020925Healqu90209052023-11-08
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

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Primary DI, Brand, Company table
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10840330705032ProCureTwin Med, LLCNAD2026-04-22
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10197344169559MEDLINEMEDLINE INDUSTRIES, INC.NAD2025-11-14
10197344162512MEDLINEMEDLINE INDUSTRIES, INC.NAD2025-11-07
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