FDA.report

Health Smart

Primary DI
10767056181479
Brand
Health Smart
Company
Guangzhou Berrcom Medical Device Co., Ltd
Model
NC003
Published
2024-01-16
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

Related Records

Product Codes

CodeName
KMAIrrigator, Powered Nasal

Product Code Classifications

CodeDeviceSpecialtyClass
KMAIrrigator, Powered NasalEar, Nose, Throat1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
10767056181479PackageGS140In Commercial Distribution
00767056181472PrimaryGS10

GMDN Terms

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.

Sterilization Methods

Method

Regulatory Flags

DUNS number
529391821
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
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

Other Devices From This Company

Primary DIBrandModelCatalogPublished
56947656117937BERRCOMJXB-1832026-01-21
36947656118015BerrcomJXB-1782026-01-21
66947656118023DedeksDT1192026-01-21
66947656118030DedeksDT1162026-01-21
66947656118047DedeksDT1132026-01-21
46947656118050BERRCOMET1022026-01-21
26947656112948COCOBEARJXB-1782025-09-29
76947656114442DormDocDT0082025-09-29
46947656117701BERRCOMET1022025-08-28
56947656115315BERRCOMDT0072024-01-10
66947656116685SprucelyDT1132024-12-16
16947656116260BPET1072024-10-15
56947656116251BerrcomDT0072024-09-26
56947656116213SnomdJXB-3012024-09-21
56947656116220SnomdJXB-3022024-09-21
56947656116091SnomdET0032024-08-20
36947656116059SnomdJXB-1782024-07-29
56947656115902BerrcomJXB-1782024-07-17
16947656115829BERRCOMNC0062024-06-12
16947656115836BERRCOMNC0072024-06-12

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
00850079671003Naväge Rhinosystems, Inc.KMA2026-02-23
00763000548797HydrodebriderMEDTRONIC XOMED, INC.KMA2026-02-14
00763000548803HydrodebriderMEDTRONIC XOMED, INC.KMA2026-02-14
10057475491502BIOS DiagnosticsThermor LtdKMA2026-01-19
06978785665131InhwRiorShenzhen Yuechuan trade Co., Ltd.KMA2025-12-08
16971919460449Medi GradeNingbo Albert Novosino Co.,Ltd.KMA2025-11-17
00892773001168SinuPulseHealth Solutions Medical Products CorporationKMA2025-08-28
06978785665063InhwRiorShenzhen Yuechuan trade Co., Ltd.KMA2025-08-08
10850044118844iHealthIHEALTH LAB INC.KMA2024-11-18
10850044118868iHealthIHEALTH LAB INC.KMA2024-10-30
10767056181530HealthSmartD-M-S HOLDINGS, INC.KMA2024-09-25
10057475160514BIOS DiagnosticsThermor LtdKMA2024-06-17
16947656115836BERRCOMGuangzhou Berrcom Medical Device Co., LtdKMA2024-06-12
00810051084849GuruNanda Portable Nasal IrrigatorGurunanda, LLCKMA2024-03-11
10767056181523HealthSmartD-M-S HOLDINGS, INC.KMA2024-01-26
06975983273120MomcozyShenzhen Lutejiacheng Supply Chain Management Co., Ltd.KMA2024-01-10
00892773001199SinuPulseHealth Solutions Medical Products CorporationKMA2023-11-04
00892773001182SinuPulseHealth Solutions Medical Products CorporationKMA2023-08-25
00892773001137SinuPulseHealth Solutions Medical Products CorporationKMA2023-06-16
26947656114713BerrcomGuangzhou Berrcom Medical Device Co., LtdKMA2023-05-22
04035873069287Cleaning sheath for Ø4mm X 155mm 0°Henke-Sass, Wolf GmbHKMA2022-05-01
04035873069294Cleaning sheath for Ø4mm X 155mm 30°Henke-Sass, Wolf GmbHKMA2022-05-01
04035873069300Cleaning sheath for Ø4mm X 155mm 45°Henke-Sass, Wolf GmbHKMA2022-05-01
04035873069317Cleaning Sheath for Ø4mm X 155mm 70°Henke-Sass, Wolf GmbHKMA2022-05-01
04035873069324Cleaning sheath for Ø4mm X 155mm 30° RHenke-Sass, Wolf GmbHKMA2022-05-01
04035873069331Cleaning sheath for Ø4mm X 155mm 45° RHenke-Sass, Wolf GmbHKMA2022-05-01
04035873069348Cleaning sheath for Ø4mm X 155mm 70° RHenke-Sass, Wolf GmbHKMA2022-05-01
04035873069355Cleaning sheath for Ø4mm X 180mm 0°Henke-Sass, Wolf GmbHKMA2022-05-01
04035873069362Cleaning sheath for Ø4mm X 180mm 30°Henke-Sass, Wolf GmbHKMA2022-05-01
04035873069379Cleaning sheath for Ø4mm X 180mm 30° RHenke-Sass, Wolf GmbHKMA2022-05-01