FDA.reportPublic FDA data

Hetaida

Primary DI
16970289035721
Brand
Hetaida
Company
Hetaida Technology Co., Ltd
Model
HTD2601US
Device description
Electric Nasal Aspirator
Published
2024-08-15
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
BTAPump, Portable, Aspiration (Manual Or Powered)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
BTAPump, Portable, Aspiration (Manual Or Powered)General, Plastic Surgery2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K241202000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K241202000Electric nasal aspirator (HTD2601US)Hetaida Technology Co., Ltd.2024-07-01BTA

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
16970289035721PackageGS140In Commercial Distribution
06970289035724PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1697028903572116970289035721
06970289035724069702890357246970289035724

GMDN Terms#

Term, Definition table
TermDefinition
Nasal aspirator, electricA portable, hand-held, battery-powered suction device designed to enable an adult to gently suction and clear excessive mucus from the nasal passages of an infant or child to facilitate easier breathing. It consists of a handgrip that contains the batteries, a small electric pump that creates the suction, and typically has a silicone nozzle attached to a detachable, washable, collection cup at the distal end. It is designed for domestic use and is typically applied superficially the nasal opening (i.e., not inserted into the nasal cavity). This is a reusable device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Atmospheric Pressure70 KiloPascal106 KiloPascal
Handling Environment Humidity15 Percent (%) Relative Humidity85 Percent (%) Relative Humidity
Handling Environment Temperature5 Degrees Celsius40 Degrees Celsius
Storage Environment Atmospheric Pressure70 KiloPascal106 KiloPascal
Storage Environment Humidity10 Percent (%) Relative Humidity93 Percent (%) Relative Humidity
Storage Environment Temperature-20 Degrees Celsius55 Degrees Celsius

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
false
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
06970462546832Suction PumpShenzhen HugeMed Medical Technical Development Co., Ltd.BTA2026-06-04
00860014862731HEYVALUEOak Tech LLCBTA2026-03-27
00860014862748GROWNSYOak Tech LLCBTA2026-03-27
10845854041413APEXConmed CorporationBTA2026-03-23
10845854080153CONMEDConmed CorporationBTA2026-03-23
00810149098246R&D Batteries, Inc.R & D Batteries, Inc.BTA2026-02-12
00810149098222R&D Batteries, Inc.R & D Batteries, Inc.BTA2026-01-20
00860014862700GROWNSYOak Tech LLCBTA2026-01-10
00860014862717GROWNSYOak Tech LLCBTA2026-01-10
00860014862724GROWNSYOak Tech LLCBTA2026-01-10
06973222511606Electric Nasal AspiratorShenzhen Desida Technology Co., Ltd.BTA2025-12-31
00810149098178R&D Batteries, Inc.R & D Batteries, Inc.BTA2025-10-27
00860014577550HEYVALUEOak Tech LLCBTA2025-10-13
00860014577567HEYVALUEOak Tech LLCBTA2025-10-13
00860014577574HEYVALUEOak Tech LLCBTA2025-10-13
00860014577581HEYVALUEOak Tech LLCBTA2025-10-13
00860014577505GROWNSYOak Tech LLCBTA2025-08-26
00860014577512GROWNSYOak Tech LLCBTA2025-08-26
00860014577529GROWNSYOak Tech LLCBTA2025-08-26
06953775661706BBLOVEAlicn Medical Shenzhen, Inc.BTA2025-08-04
07640108052506Endoskopiepumpe Master distributed by KARL STORZ UP033C, 115V, mit FussschalterArdo medical AGBTA2025-07-16
07640108053374Endoskopiepumpe Senator distributed by KARL STORZ UP030C, 115VArdo medical AGBTA2025-07-16
07640108055293Endoskopiepumpe Master distributed by KARL STORZ UP034C, 115VArdo medical AGBTA2025-07-16
00810149097997R&D Batteries, Inc.R & D Batteries, Inc.BTA2025-06-23
00810149097973R&D Batteries, Inc.R & D Batteries, Inc.BTA2025-06-18
00810149097980R&D Batteries, Inc.R & D Batteries, Inc.BTA2025-06-18
06975740361558MomcozyShenzhen Root Innovation Technology Co., Ltd.BTA2025-05-20
06978331170218BASENDongguan Yiyingmei Technology Co., Ltd.BTA2025-03-31
06978331170232BASENDongguan Yiyingmei Technology Co., Ltd.BTA2025-03-31
06978331170249BASENDongguan Yiyingmei Technology Co., Ltd.BTA2025-03-31