FDA.reportPublic FDA data

iHealth

Primary DI
00850044118847
Brand
iHealth
Company
iHealth Labs Inc.
Model
3.6g*90
Published
2024-11-18
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true
Single use
true

Product Codes#

Code, Name table
CodeName
KMAIrrigator, Powered Nasal

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KMAIrrigator, Powered NasalEar, Nose, Throat1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10850044118844PackageGS120In Commercial Distribution
00850044118847PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1085004411884410850044118844
00850044118847008500441188478500441188470850044118847

GMDN Terms#

Term, Definition table
TermDefinition
Hydrotherapy solute A mixture of primarily inorganic salts (e.g., sodium, potassium, chloride, bicarbonate, sulphide, sulphate) intended to be dissolved in water for a hydrotherapy mineral bath. It provides a supportive agent to the hydrotherapy used for a variety of clinical applications. This is a single-use device.

Regulatory Flags#

DUNS number
054953337
Device count
1
Premarket exempt
true
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850044118045iHealthICO-30002022-09-30
00850044118236iHealthBG5SKIT2024-05-28
00850044118243iHealthBG5SKIT2024-05-27
00856362005043iHealthPT32020-07-31
00856362005159iHealthBG5SKIT2025-12-19
00850044118083iHealthPT32023-08-14
00850044118007iHealthKD-7232022-09-29
00850044118205iHealthEGS-20032023-08-24
00850044118250iHealthEGS-20032023-08-30
00850044118267iHealthEGS-20032023-08-30
00850044118694iHealthPT2L2025-12-19
00850044118700iHealthPT9L2025-12-19
00850044118724iHealthPT9L2025-12-19
00850044118823iHealthKD-5811BT2026-04-15
00850044118830iHealthKD-5811BT2026-04-15
00850044118960iHealthBP-300CL2025-12-10
00850078377081iHealthKN-550BT2025-12-19
00855111003279iHealthPO32023-08-14
00855111003958iHealthBP3L2022-09-30
00856362005005iHealthKN-550BT2022-10-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00850079671003Naväge Rhinosystems, Inc.KMA2026-02-23
00763000548797HydrodebriderMEDTRONIC XOMED, INC.KMA2026-02-14
00763000548803HydrodebriderMEDTRONIC XOMED, INC.KMA2026-02-14
00057475491505BIOS DiagnosticsThermor LtdKMA2026-01-19
10057475491502BIOS DiagnosticsThermor LtdKMA2026-01-19
06978785665131InhwRiorShenzhen Yuechuan trade Co., Ltd.KMA2025-12-08
00763000435905Hydrodebrider™MEDTRONIC XOMED, INC.KMA2025-11-22
16971919460449Medi GradeNingbo Albert Novosino Co.,Ltd.KMA2025-11-17
06947656114610BERRCOMGuangzhou Berrcom Medical Device Co., LtdKMA2025-10-13
00892773001168SinuPulseHealth Solutions Medical Products CorporationKMA2025-08-28
06978785665063InhwRiorShenzhen Yuechuan trade Co., Ltd.KMA2025-08-08
00850027492957NavägeRhinosystems, Inc.KMA2025-07-08
00805106849603XTREMEXtreme Personal Care Inc.KMA2025-04-20
00850044118793iHealthiHealth Labs Inc.KMA2024-12-10
10850044118844iHealthIHEALTH LAB INC.KMA2024-11-18
00850044118861iHealthiHealth Labs Inc.KMA2024-10-30
10850044118868iHealthIHEALTH LAB INC.KMA2024-10-30
00767056181533HealthSmartD-M-S HOLDINGS, INC.KMA2024-09-25
10767056181530HealthSmartD-M-S HOLDINGS, INC.KMA2024-09-25
00858492004958NavägeRhinosystems, Inc.KMA2024-06-20
00057475160517BIOS DiagnosticsThermor LtdKMA2024-06-17
10057475160514BIOS DiagnosticsThermor LtdKMA2024-06-17
06947656115839BERRCOMGuangzhou Berrcom Medical Device Co., LtdKMA2024-06-12
16947656115836BERRCOMGuangzhou Berrcom Medical Device Co., LtdKMA2024-06-12
00810051084849GuruNanda Portable Nasal IrrigatorGurunanda, LLCKMA2024-03-11
00767056181526HealthSmartD-M-S HOLDINGS, INC.KMA2024-01-26
10767056181523HealthSmartD-M-S HOLDINGS, INC.KMA2024-01-26
00767056181472Health Smart Guangzhou Berrcom Medical Device Co., LtdKMA2024-01-16
10767056181479Health Smart Guangzhou Berrcom Medical Device Co., LtdKMA2024-01-16
06975983273021MomcozyShenzhen Lutejiacheng Supply Chain Management Co., Ltd.KMA2024-01-10