FDA.reportPublic FDA data

Welly

Primary DI
00372663000100
Brand
Welly
Company
WELLY HEALTH PBC
Model
WLY1054
Device description
First Aid - On The Go Colorwash
Published
2020-09-01
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
LRRFirst Aid Kit With Drug

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LRRFirst Aid Kit With DrugUnknownN

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00372663000100PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00372663000100003726630001003726630001000372663000100

GMDN Terms#

Term, Definition table
TermDefinition
First aid kit, medicatedA convenient collection of equipment, materials and pharmaceuticals intended to be used in an emergency for the rapid, initial treatment of an injury. It is typically used by emergency medical services (EMS), hospitals, institutions, schools, and other public settings. This is a reusable device.

Sterilization Methods#

Method table
Method
Ethylene Oxide

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
Expiration date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00372663000018WellyWLY10382020-09-01
00372663000056WellyWLY10432020-09-01
00372663000063WellyWLY10442020-09-01
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
00810010440112WellyWLY10122020-09-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06942509220548OP - First aid seriesYiwu Ori-Power Medtech Co.,Ltd.LRR2026-08-22
06942509220555OP - First aid seriesYiwu Ori-Power Medtech Co.,Ltd.LRR2026-08-22
06942509220562OP - First aid seriesYiwu Ori-Power Medtech Co.,Ltd.LRR2026-08-22
06942509220579OP - First aid seriesYiwu Ori-Power Medtech Co.,Ltd.LRR2026-08-22
06942509220630OP - First aid seriesYiwu Ori-Power Medtech Co.,Ltd.LRR2026-08-22
06942509220654OP - First aid seriesYiwu Ori-Power Medtech Co.,Ltd.LRR2026-08-22
06942509220661OP - First aid seriesYiwu Ori-Power Medtech Co.,Ltd.LRR2026-08-22
06942509220678OP - First aid seriesYiwu Ori-Power Medtech Co.,Ltd.LRR2026-08-22
06942509220739OP - First aid seriesYiwu Ori-Power Medtech Co.,Ltd.LRR2026-08-22
06942509220753OP - First aid seriesYiwu Ori-Power Medtech Co.,Ltd.LRR2026-08-22
06942509220760OP - First aid seriesYiwu Ori-Power Medtech Co.,Ltd.LRR2026-08-22
06942509220777OP - First aid seriesYiwu Ori-Power Medtech Co.,Ltd.LRR2026-08-22
06942509220784OP - First aid seriesYiwu Ori-Power Medtech Co.,Ltd.LRR2026-08-22
06942509220807OP - First aid seriesYiwu Ori-Power Medtech Co.,Ltd.LRR2026-08-22
06942509220814OP - First aid seriesYiwu Ori-Power Medtech Co.,Ltd.LRR2026-08-22
06942509220821OP - First aid seriesYiwu Ori-Power Medtech Co.,Ltd.LRR2026-08-22
06942509220838OP - First aid seriesYiwu Ori-Power Medtech Co.,Ltd.LRR2026-08-22
06942509220845OP - First aid seriesYiwu Ori-Power Medtech Co.,Ltd.LRR2026-08-22
06942509220852OP - First aid seriesYiwu Ori-Power Medtech Co.,Ltd.LRR2026-08-22
06942509220869OP - First aid seriesYiwu Ori-Power Medtech Co.,Ltd.LRR2026-08-22
06942509220876OP - First aid seriesYiwu Ori-Power Medtech Co.,Ltd.LRR2026-08-22
06942509220883OP - First aid seriesYiwu Ori-Power Medtech Co.,Ltd.LRR2026-08-22
06942509220920OP - First aid seriesYiwu Ori-Power Medtech Co.,Ltd.LRR2026-08-22
06942509220937OP - First aid seriesYiwu Ori-Power Medtech Co.,Ltd.LRR2026-08-22
00766588260143Watercraft First Aid Kit - 16 Poly WhiteCertified Safety Manufacturing, Inc.LRR2026-08-19
00766588260181Teichert Clas A 21 - 18 MetalCertified Safety Manufacturing, Inc.LRR2026-08-19
00842209139682NARNORTH AMERICAN RESCUE, LLCLRR2026-08-19
00842209139699NARNORTH AMERICAN RESCUE, LLCLRR2026-08-19
00842209139712NARNORTH AMERICAN RESCUE, LLCLRR2026-08-19
00842209139729NARNORTH AMERICAN RESCUE, LLCLRR2026-08-19