FDA.reportPublic FDA data

Welly

Primary DI
00810010440112
Brand
Welly
Company
WELLY HEALTH PBC
Model
WLY1012
Device description
Waterproof Flexible Foam Tape
Published
2020-09-01
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Contact Domains#

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
00810010440112PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810010440112008100104401128100104401120810010440112

GMDN Terms#

Term, Definition table
TermDefinition
Waterproof skin adhesive tapeA long and narrow flexible band that is coated on one side with a pressure-sensitive adhesive, and made from a material designed to resist water permeation, intended to be used to cover a surface (e.g., small wound), fix a dressing, attach objects, and/or exert pressure on a body part; it is not hypoallergenic. This is a single-use device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
1-833-239-3559hello@getwelly.com

Regulatory Flags#

DUNS number
116766884
Device count
1
Premarket exempt
true
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00372663000018WellyWLY10382020-09-01
00372663000056WellyWLY10432020-09-01
00372663000063WellyWLY10442020-09-01
00372663000100WellyWLY10542020-09-01
00372663000117WellyWLY1014C2020-09-01
00372663000315WellyWLY1013C2020-09-01
00372663120143WellyWLY10132020-09-01
00372663130234WellyWLY10142020-09-01
00372663171053WellyWLY10272020-09-01
00810010440006WellyWLY10012020-09-01
00810010440013WellyWLY10022020-09-01
00810010440020WellyWLY10032020-09-01
00810010440037WellyWLY10042020-09-01
00810010440044WellyWLY10052020-09-01
00810010440051WellyWLY10062020-09-01
00810010440068WellyWLY10072020-09-01
00810010440075WellyWLY10082020-09-01
00810010440082WellyWLY10092020-09-01
00810010440099WellyWLY10102020-09-01
00810010440105WellyWLY10112020-09-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00050428142516CVSWOONSOCKET PRESCRIPTION CENTER, INCORPORATEDKGX2026-05-28
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