FDA.reportPublic FDA data

Hetaida

Primary DI
16970289035844
Brand
Hetaida
Company
Hetaida Technology Co., Ltd
Model
K5102US
Published
2025-05-12
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
Sterile
false
Single use
false

Contact Domains#

Product Codes#

Code, Name table
CodeName
INBAttachment, Commode, Wheelchair

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
INBAttachment, Commode, WheelchairPhysical Medicine1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
16970289035844PackageGS1120In Commercial Distribution
06970289035847PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1697028903584416970289035844
06970289035847069702890358476970289035847

GMDN Terms#

Term, Definition table
TermDefinition
Vaginal douche, reusableA manual device designed to produce and direct a stream of fluid (typically water, water/vinegar solution, or antiseptic chemicals) into the vaginal cavity typically for hygienic purposes, including the removal of vaginal discharge, medicinal deposits, and anticonceptual products from the vagina. It usually consists of a bag, bottle, or bulb to contain the fluid, and tubing often with a nozzle for vaginal insertion; the fluid is ejected upon hand compression by the user. The device is normally available [non-prescription] over-the-counter (OTC) for use in the home or healthcare facility. This is a reusable device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+86076983326886tomchen@hetaida.com.cn

Regulatory Flags#

DUNS number
544474402
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06970289030118hetaidaHTD8216C2026-05-24
06970289035120hetaidaHTD8823US2026-05-24
06970289035137hetaidaHTD8808C2026-05-23
06970289035144hetaidaHTD8208C2026-05-23
06970289030002Infrared Body ThermometerHTD8216C2019-03-28
06970289030040HetaidaHTD8813C2019-01-10
06970289030057HetaidaHTD8819C2019-01-10
06970289030064Infrared Ear ThermometerHTD8208C2019-03-28
06970289035335HetaidaHTD8808C2021-07-27
06970289035342HetaidaHTD8222US2021-11-06
06970289035397joyhicareH8830US2021-10-29
06970289035496HetaidaHTD8813C2022-03-21
06970289035502HetaidaHTD8813C2022-03-21
06970289035519YOOKOHTD8823US2022-05-31
06970289035670hetaidaHTD8819C2024-03-14
06970289035687HetaidaHTD6603US2024-03-14
06970289035694HetaidaH2605US2024-03-14
06970289035724HetaidaHTD2601US2024-08-15
06970289035731HetaidaHTD2602US2024-08-15
00199874040318VIEKHTD8816C2026-05-12

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810178887644ViveVIVE HEALTH LLCINB2026-04-27
00810178884476ViveVIVE HEALTH LLCINB2026-02-02
00810178883806Vive VIVE HEALTH LLCINB2026-01-30
00860014905216MultichairNuprodx, Inc.INB2026-01-27
20885380068321CARDINAL HEALTHCardinal Health 200, LLCINB2025-12-29
50885380068322CARDINAL HEALTHCardinal Health 200, LLCINB2025-12-29
00815027012826DALTON COMMODE CHAIRDALTON MEDICAL CORPORATIONINB2025-09-18
00815027012833DALTON COMMODE CHAIRDALTON MEDICAL CORPORATIONINB2025-09-18
00815027012840DALTON TOILET SEATDALTON MEDICAL CORPORATIONINB2025-09-18
06970289035847HetaidaHetaida Technology Co., LtdINB2025-05-12
00194346231423Parent's ChoiceWAL-MART STORES, INC.INB2024-10-29
10194346231420Parent's ChoiceWAL-MART STORES, INC.INB2024-10-29
06976203345221GilogaZhongshan Jiale Rehabilitation Medical Equipment Co., LtdINB2024-07-01
06970289035649HetaidaHetaida Technology Co., LtdINB2024-03-14
16970289035646HetaidaHetaida Technology Co., LtdINB2024-03-14
00810113574219ViveVIVE HEALTH LLCINB2024-01-05
00041298370093HealthSmartD-M-S HOLDINGS, INC.INB2023-07-24
10041298370090HealthSmartD-M-S HOLDINGS, INC.INB2023-07-24
00822383008325DriveDrive Devilbiss HealthcareINB2022-02-01
50822383008320DriveDrive Devilbiss HealthcareINB2022-02-01
M3682195A41LUMEX GF HEALTH PRODUCTS, INC.INB2021-07-14
M3682215B21LUMEX GF HEALTH PRODUCTS, INC.INB2021-07-14
M3682195A40LUMEX GF HEALTH PRODUCTS, INC.INB2021-07-14
M3682215B20LUMEX GF HEALTH PRODUCTS, INC.INB2021-07-14
M368603904A1LUMEX GF HEALTH PRODUCTS, INC.INB2021-07-14
M36890761752J1Everest & JenningsGF HEALTH PRODUCTS, INC.INB2020-12-09
M3689B007700J1Everest & JenningsGF HEALTH PRODUCTS, INC.INB2020-12-09
M3689B045035J1Everest & JenningsGF HEALTH PRODUCTS, INC.INB2020-12-09
M3689B232870J1Everest & JenningsGF HEALTH PRODUCTS, INC.INB2020-12-09
M3689B47320J1Everest & JenningsGF HEALTH PRODUCTS, INC.INB2020-12-09