FDA.reportPublic FDA data

iHealth

Primary DI
00850044118793
Brand
iHealth
Company
iHealth Labs Inc.
Model
ANC1
Published
2024-12-10
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
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
10850044118790PackageGS112In Commercial Distribution
00850044118793PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1085004411879010850044118790
00850044118793008500441187938500441187930850044118793

GMDN Terms#

Term, Definition table
TermDefinition
Nasal lavage systemA device assembly designed for automated or semi-automated irrigation and washing of tissue and/or debris from the nose and/or the nasal sinuses. It typically consists of a main electromechanical unit that includes a pump for irrigation/infusion of a jet of non-medicated liquid (e.g., saline); controls for the rate and pressure of irrigation; a reservoir for the solution; and a handpiece that may include a set of detachable tips intended for introduction into the nostrils. The system is used mainly for allergy treatment, nasal congestion, and before and after surgery.

Regulatory Flags#

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

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00856362005814iHealthPT12021-04-01
00850044118656iHealthICF-3000P2026-05-15
00850078377180iHealthICR-30002026-05-15
00850078377272iHealthCSW-ANSCR2026-05-15
00850044118427iHealthICF-30002024-05-25
00850044118434iHealthICF-30002024-05-24
00850044118458iHealthICF-30002024-05-24
00856362005890iHealthICO-30002022-09-16
00856362005906iHealthICO-30002022-09-16
00850044118205iHealthEGS-20032023-08-24
00850044118236iHealthBG5SKIT2024-05-28
00850044118250iHealthEGS-20032023-08-30
00850044118267iHealthEGS-20032023-08-30
00856362005005iHealthKN-550BT2022-10-01
00856362005050iHealthBPM12023-08-14
00856362005104iHealthBP3L2022-09-30
00856362005142iHealthBP5S2025-03-03
00856362005159iHealthBG5SKIT2025-12-19
00856362005197iHealthEGS-20032019-01-09
00856362005821iHealthPT3SBT2021-04-14

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
00850044118847iHealthiHealth Labs Inc.KMA2024-11-18
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