FDA.reportPublic FDA data

Hetaida

Primary DI
16970289035738
Brand
Hetaida
Company
Hetaida Technology Co., Ltd
Model
HTD2602US
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)
KDQBottle, Collection, Vacuum

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
BTAPump, Portable, Aspiration (Manual Or Powered)General, Plastic Surgery2
KDQBottle, Collection, VacuumGeneral Hospital2

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
16970289035738PackageGS140In Commercial Distribution
06970289035731PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1697028903573816970289035738
06970289035731069702890357316970289035731

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
06970289035946hetaidaH8830US2026-10-16
06970289035953hetaidaH8830US2026-10-16
06970289035960hetaidaH8601US2026-10-16
06970289035977hetaidaH8601US2026-10-16
06970289030859foreverlittleK8832US2026-07-28
06970289030866foreverlittleH2603US2026-07-28
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810130457274Medco Manufacturing IncMedco Manufacturing LLCKDQ2026-10-23
10197344219261MEDLINEMEDLINE INDUSTRIES, INC.KDQ2026-10-23
06936603231340Collector OneYangzhou Fartley Medical Instrument Technology Co., LtdKDQ2026-10-22
10197344219254MEDLINEMEDLINE INDUSTRIES, INC.KDQ2026-10-16
06978731720013Electric nasal aspiratorShenzhen Kingboom Technology Co., Ltd.BTA2026-10-12
06978731720020Electric nasal aspiratorShenzhen Kingboom Technology Co., Ltd.BTA2026-10-12
06978731720037Electric nasal aspiratorShenzhen Kingboom Technology Co., Ltd.BTA2026-10-12
06978731720044Electric nasal aspiratorShenzhen Kingboom Technology Co., Ltd.BTA2026-10-12
06978731720051Electric nasal aspiratorShenzhen Kingboom Technology Co., Ltd.BTA2026-10-12
06978731720068Electric nasal aspiratorShenzhen Kingboom Technology Co., Ltd.BTA2026-10-12
06978731720075Electric nasal aspiratorShenzhen Kingboom Technology Co., Ltd.BTA2026-10-12
06978731720082Electric nasal aspiratorShenzhen Kingboom Technology Co., Ltd.BTA2026-10-12
06978731720099Electric nasal aspiratorShenzhen Kingboom Technology Co., Ltd.BTA2026-10-12
06978731720105Electric nasal aspiratorShenzhen Kingboom Technology Co., Ltd.BTA2026-10-12
06978731720112Electric nasal aspiratorShenzhen Kingboom Technology Co., Ltd.BTA2026-10-12
00749756402989DeRoyalDEROYAL INDUSTRIES, INC.KDQ2026-09-30
00749756402996DeRoyalDEROYAL INDUSTRIES, INC.KDQ2026-09-30
00749756403009DeRoyalDEROYAL INDUSTRIES, INC.KDQ2026-09-30
00749756403016DeRoyalDEROYAL INDUSTRIES, INC.KDQ2026-09-30
00749756403023DeRoyalDEROYAL INDUSTRIES, INC.KDQ2026-09-30
14026704911773PLEUR-EVACTELEFLEX INCORPORATEDKDQ2026-08-01
06970289030866foreverlittleHetaida Technology Co., LtdBTA2026-07-28
04719874957476Create BiotechCREATE BIOTECH CO., LTD.KDQ2026-07-21
00842429118689MV Flow Aspiration PumpMicrovention, Inc.BTA2026-07-15
00850040296464AOJShenzhen AOJ Health Science & Technology Co., Ltd.KDQ2026-07-11
00850079671102NavägeRhinosystems, Inc.KDQ2026-06-10
06970462546832Suction PumpShenzhen HugeMed Medical Technical Development Co., Ltd.BTA2026-06-04
10845854041413APEXConmed CorporationBTA2026-03-23
14026704912190PLEUR-EVACTELEFLEX INCORPORATEDKDQ2025-09-17
14026704911780PLEUR-EVACTELEFLEX INCORPORATEDKDQ2025-09-04