FDA.reportPublic FDA data

Healqu

Primary DI
00819143020888
Brand
Healqu
Company
Healqu LLC
Model
9020901
Device description
Healqu Transparent Dressing (23/8 x 23/4)
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
00819143024114PackageGS120In Commercial Distribution
00819143024121PackageGS140In Commercial Distribution
00819143025203PackageGS120In Commercial Distribution
00819143025210PackageGS140In Commercial Distribution
00819143025302PackageGS1100In Commercial Distribution
00819143025319PackageGS14In Commercial Distribution
00819143025449PackageGS120In Commercial Distribution
00819143025456PackageGS140In Commercial Distribution
00819143025609PackageGS1100In Commercial Distribution
00819143025616PackageGS14In Commercial Distribution
00819143026507PackageGS112In Commercial Distribution
20819143020882PackageGS14In Commercial Distribution
30819143020889PackageGS1100In Commercial Distribution
00819143020888PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00819143024114008191430241148191430241140819143024114
00819143024121008191430241218191430241210819143024121
00819143025203008191430252038191430252030819143025203
00819143025210008191430252108191430252100819143025210
00819143025302008191430253028191430253020819143025302
00819143025319008191430253198191430253190819143025319
00819143025449008191430254498191430254490819143025449
00819143025456008191430254568191430254560819143025456
00819143025609008191430256098191430256090819143025609
00819143025616008191430256168191430256160819143025616
00819143026507008191430265078191430265070819143026507
2081914302088220819143020882
3081914302088930819143020889
00819143020888008191430208888191430208880819143020888

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
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
00819143025739HealquCA-902274112025-08-21

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10840330701645ProCureTwin Med, LLCNAD2026-04-28
10840330701652ProCureTwin Med, LLCNAD2026-04-28
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10197344169559MEDLINEMEDLINE INDUSTRIES, INC.NAD2025-11-14
10197344162512MEDLINEMEDLINE INDUSTRIES, INC.NAD2025-11-07
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