FDA.reportPublic FDA data

Healqu

Primary DI
00819143026446
Brand
Healqu
Company
Healqu LLC
Model
US-90227211
Device description
Healqu Non-woven Retention Tape 2in x 11yds
Published
2026-03-05
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Product Codes#

Code, Name table
CodeName
KGXTape And Bandage, Adhesive

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KGXTape And Bandage, AdhesiveGeneral Hospital1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00819143026453PackageGS124In Commercial Distribution
00819143026446PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00819143026453008191430264538191430264530819143026453
00819143026446008191430264468191430264460819143026446

GMDN Terms#

Term, Definition table
TermDefinition
Dressing-fixation skin adhesive tape, non-siliconeA long and narrow flexible band of non-silicone-based material (e.g., fabric, plastic, paper) coated on one or both sides with a pressure-sensitive adhesive, intended to non-invasively adhere to the skin surface to fix a dressing in place or attach objects (e.g., catheter, lamp); it might have hypoallergenic and/or waterproof properties. 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
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
00819143025739HealquCA-902274112025-08-21

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
09420012436047Fisher & Paykel HealthcareFISHER & PAYKEL HEALTHCARE LIMITEDKGX2026-04-14
09420012436061Fisher & Paykel HealthcareFISHER & PAYKEL HEALTHCARE LIMITEDKGX2026-04-14
10192253049817TelfaCardinal Health 200, LLCKGX2026-02-25
10192253050080TelfaCardinal Health 200, LLCKGX2026-02-25
10080196669523MEDLINEMEDLINE INDUSTRIES, INC.KGX2026-01-30
10080196669530MEDLINEMEDLINE INDUSTRIES, INC.KGX2026-01-30
10080196669547MEDLINEMEDLINE INDUSTRIES, INC.KGX2026-01-30
10618125192318AquaGuardTIDI PRODUCTS, LLCKGX2025-09-23
10198459392078MEDLINE INDUSTRIES, INC.MEDLINE INDUSTRIES, INC.KGX2025-07-07
10080196691708CURADMEDLINE INDUSTRIES, INC.KGX2025-05-23
10198459343506MEDLINE INDUSTRIES, INC.MEDLINE INDUSTRIES, INC.KGX2025-05-22
10192253050172TelfaCardinal Health 200, LLCKGX2025-04-18
10192253050189TelfaCardinal Health 200, LLCKGX2025-04-18
10385081120333Omnipod PodPalsInsulet CorporationKGX2025-04-16
10653160999003Centurion Medical Products CorpMEDLINE INDUSTRIES, INC.KGX2025-04-07
10197106767726CARDINAL HEALTHCardinal Health 200, LLCKGX2024-10-31
10080196669417MEDLINEMEDLINE INDUSTRIES, INC.KGX2024-07-31
10080196669493MEDLINEMEDLINE INDUSTRIES, INC.KGX2024-07-31
10080196743032MEDLINEMEDLINE INDUSTRIES, INC.KGX2024-07-31
09355751001259Seer HomeSEER MEDICAL HOLDINGS LIMITEDKGX2024-06-27
10197344102716MEDLINEMEDLINE INDUSTRIES, INC.KGX2024-06-20
10197344102723MEDLINEMEDLINE INDUSTRIES, INC.KGX2024-06-20
10197344102730MEDLINEMEDLINE INDUSTRIES, INC.KGX2024-06-20
10197344102747MEDLINEMEDLINE INDUSTRIES, INC.KGX2024-06-20
10197344102754MEDLINEMEDLINE INDUSTRIES, INC.KGX2024-06-20
10197344102761MEDLINEMEDLINE INDUSTRIES, INC.KGX2024-06-20
10197344102778MEDLINEMEDLINE INDUSTRIES, INC.KGX2024-06-20
10197344102785MEDLINEMEDLINE INDUSTRIES, INC.KGX2024-06-20
10192253046779KendallCardinal Health 200, LLCKGX2024-06-11
10192253046304KendallCardinal Health 200, LLCKGX2024-05-29