FDA.reportPublic FDA data

Evert-It

Primary DI
00683693360004
Brand
Evert-It
Company
Mai/Genesis
Model
36000
Catalog number
36000
Device description
Evert-It Nipple Enhancer
Published
2023-09-12
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
HGYPump, Breast, Non-Powered

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HGYPump, Breast, Non-PoweredObstetrics/Gynecology1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K962828000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K962828000EVERT-ITGenesis Industries, Inc.1997-02-10HGY

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00683693360004PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00683693360004006836933600046836933600040683693360004

GMDN Terms#

Term, Definition table
TermDefinition
Breast pump, manualA hand-held device used to extract milk from the breast, typically for collecting and feeding to an infant. The device produces a low-grade suction through a funnel-like component that is applied to the breast and is typically operated by the donor; the milk collects in an attached vessel (e.g., a sterilized bottle). This is a reusable device.

Regulatory Flags#

DUNS number
078873500
Device count
1

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00719113275860Vaginal Applicator27586275862023-09-14

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
09420060215045haakaaTHINK GREEN LIMITEDHGY2026-09-21
09420060215052haakaaTHINK GREEN LIMITEDHGY2026-09-21
09420060215083haakaaTHINK GREEN LIMITEDHGY2026-09-21
09420060215090haakaaTHINK GREEN LIMITEDHGY2026-09-21
09420060215106haakaaTHINK GREEN LIMITEDHGY2026-09-21
09420060215113haakaaTHINK GREEN LIMITEDHGY2026-09-21
09420060215120haakaaTHINK GREEN LIMITEDHGY2026-09-21
09420060215137haakaaTHINK GREEN LIMITEDHGY2026-09-21
09420060216011haakaaTHINK GREEN LIMITEDHGY2026-09-21
09420060216028haakaaTHINK GREEN LIMITEDHGY2026-09-21
09420060216035haakaaTHINK GREEN LIMITEDHGY2026-09-21
09420060214123haakaaTHINK GREEN LIMITEDHGY2026-09-20
09420060214130haakaaTHINK GREEN LIMITEDHGY2026-09-20
09420060214147haakaaTHINK GREEN LIMITEDHGY2026-09-20
09420060214154haakaaTHINK GREEN LIMITEDHGY2026-09-20
09420060201055haakaaTHINK GREEN LIMITEDHGY2026-09-18
09420060201062haakaaTHINK GREEN LIMITEDHGY2026-09-18
09420060201079haakaaTHINK GREEN LIMITEDHGY2026-09-18
09420060201086haakaaTHINK GREEN LIMITEDHGY2026-09-18
09420060201093haakaaTHINK GREEN LIMITEDHGY2026-09-18
09420060201680haakaaTHINK GREEN LIMITEDHGY2026-09-18
09420060201697haakaaTHINK GREEN LIMITEDHGY2026-09-18
09420060201703haakaaTHINK GREEN LIMITEDHGY2026-09-18
09420060201710haakaaTHINK GREEN LIMITEDHGY2026-09-18
06925546001882ZimeituCixi Ruihong Electric Appliance Co., Ltd.HGY2026-07-28
06925546001981ZimeituCixi Ruihong Electric Appliance Co., Ltd.HGY2026-07-28
06925546020814ZimeituCixi Ruihong Electric Appliance Co., Ltd.HGY2026-07-28
06925546002087Figaroo™ GlideCixi Ruihong Electric Appliance Co., Ltd.HGY2026-07-23
08809108019097SpectraUZINMEDICARE CO.,LTDHGY2025-10-15
00810104130936 Wave Single Manual Pump KitWILLOW INNOVATIONS, INC.HGY2025-07-23