FDA.reportPublic FDA data

Healqu

Primary DI
00819143021335
Brand
Healqu
Company
Healqu LLC
Model
9024144
Device description
Healqu Hydrocolloid Bordered Dressing 4x4
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
NACDressing, Wound, Hydrophilic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NACDressing, Wound, HydrophilicGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00819143026637PackageGS110In Commercial Distribution
00819143026644PackageGS110In Commercial Distribution
10819143021332PackageGS110In Commercial Distribution
20819143021339PackageGS110In Commercial Distribution
00819143021335PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00819143026637008191430266378191430266370819143026637
00819143026644008191430266448191430266440819143026644
1081914302133210819143021332
2081914302133920819143021339
00819143021335008191430213358191430213350819143021335

GMDN Terms#

Term, Definition table
TermDefinition
Exudate-absorbent dressing, hydrophilic-gel, non-antimicrobialA wound covering, typically made of a hydrocolloid, hydrofibre, chitosan or alginate (salts and acids extracted from seaweed), intended to produce a water-absorbent gel upon contact with wound exudate; it does not contain an antimicrobial agent. The device assists in wound healing by absorbing exudate in wounds (e.g., ulcers, burns, surgical wounds, lacerations, abrasions) for minimal wound maceration, allowing wound debridement, and creating a moist wound-healing environment. The device may be in the form of a flat sheet/film, ribbon, rope, foam, liquid, paste, or powder. After application, this device cannot be reused.

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
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
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
00819143025746HealquCA-902276112025-08-21

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