FDA.reportPublic FDA data

Welly

Primary DI
00810010440198
Brand
Welly
Company
WELLY HEALTH PBC
Model
WLY1020
Device description
Scissors, Tweezers & Clippers
Published
2020-09-01
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
OHOFirst Aid Kit Without Drug

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OHOFirst Aid Kit Without DrugGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00810010440198PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810010440198008100104401988100104401980810010440198

GMDN Terms#

Term, Definition table
TermDefinition
First aid kit, non-medicated, reusableA convenient collection of equipment and materials intended to be used in an emergency for the rapid, initial treatment of an injury. This device is typically used by emergency medical services (EMS), institutions, schools, the home, motor vehicles, and other public settings. This device does not contain medicinal substances/pharmaceuticals. This is a reusable 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
00850062467224TC3 CLS Kit, CBAltitude Technologies Inc.OHO2026-08-27
M68981129060Mojo Patrol IFAK IISafeguard US Operating, LLCOHO2026-08-26
M689SDREDC1OTC050SDR-EDC1-OTCSafeguard US Operating, LLCOHO2026-08-26
M689SDRTBBOTC060SDR Tactical Battle Belt IFAK-OTCSafeguard US Operating, LLCOHO2026-08-26
M68981139010LEO Patrol KitSafeguard US Operating, LLCOHO2026-08-25
M68981301030MARCH IFAK RefillSafeguard US Operating, LLCOHO2026-08-25
M6898130330010MARCH IFAK RESUPPLY Cs of 30Safeguard US Operating, LLCOHO2026-08-25
M68981605020K9 Trauma KitSafeguard US Operating, LLCOHO2026-08-25
M68987155030TX Bleeding Control Kit - AdvancedSafeguard US Operating, LLCOHO2026-08-25
M68987232010Stop the Bleed Kit (NJSP)Safeguard US Operating, LLCOHO2026-08-25
M689SDREDC1OTC010SDR-EDC1OTCSafeguard US Operating, LLCOHO2026-08-25
M689SDRTBBOTC020SDR Tactical Battle Belt IFAK-OTCSafeguard US Operating, LLCOHO2026-08-25
00842209139620NARNORTH AMERICAN RESCUE, LLCOHO2026-08-19
00842209139637NARNORTH AMERICAN RESCUE, LLCOHO2026-08-19
00842209139644NARNORTH AMERICAN RESCUE, LLCOHO2026-08-19
00842209139651NARNORTH AMERICAN RESCUE, LLCOHO2026-08-19
00842209139668NARNORTH AMERICAN RESCUE, LLCOHO2026-08-19
00842209139675NARNORTH AMERICAN RESCUE, LLCOHO2026-08-19
00842209139705NARNORTH AMERICAN RESCUE, LLCOHO2026-08-19
00842209139750NARNORTH AMERICAN RESCUE, LLCOHO2026-08-19
00842209139811NARNORTH AMERICAN RESCUE, LLCOHO2026-08-19
00842209139828NARNORTH AMERICAN RESCUE, LLCOHO2026-08-19
00842209139835NARNORTH AMERICAN RESCUE, LLCOHO2026-08-19
00842209139842NARNORTH AMERICAN RESCUE, LLCOHO2026-08-19
00199972000443CuraplexBOUND TREE MEDICAL, LLCOHO2026-08-15
00199972000450CuraplexBOUND TREE MEDICAL, LLCOHO2026-08-15
00850056748742Pacific BiomedicalINTEGRATED MEDCRAFT LLCOHO2026-07-31
00850056748735Pacific BiomedicalINTEGRATED MEDCRAFT LLCOHO2026-07-30
M6898723101030Bleeding Control KitSafeguard US Operating, LLCOHO2026-07-30
M6898810501060Patrol Officer IFAK BasicSafeguard US Operating, LLCOHO2026-07-27