FDA.reportPublic FDA data

Healqu

Primary DI
00819143021359
Brand
Healqu
Company
Healqu LLC
Model
9024222
Device description
Healqu Hydrocolloid Extra Thin Dressing 2x2
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
00819143025562PackageGS120In Commercial Distribution
00819143025579PackageGS110In Commercial Distribution
00819143026514PackageGS120In Commercial Distribution
00819143026521PackageGS130In Commercial Distribution
30819143021350PackageGS120In Commercial Distribution
40819143021357PackageGS110In Commercial Distribution
00819143021359PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00819143025562008191430255628191430255620819143025562
00819143025579008191430255798191430255790819143025579
00819143026514008191430265148191430265140819143026514
00819143026521008191430265218191430265210819143026521
3081914302135030819143021350
4081914302135740819143021357
00819143021359008191430213598191430213590819143021359

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
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
00819143025340HealquUS-902276112025-08-21
00819143025685HealquCA-90227211-22025-08-21
00819143025722HealquCA-902274112025-08-21
00819143025746HealquCA-902276112025-08-21

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