FDA.reportPublic FDA data

Medi Grade

Primary DI
16971919460449
Brand
Medi Grade
Company
Ningbo Albert Novosino Co.,Ltd.
Model
500ml
Device description
nasal rinse bottle
Published
2025-11-17
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

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
16971919460449PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1697191946044916971919460449

GMDN Terms#

Term, Definition table
TermDefinition
Nasal irrigation applicatorA dispensing device (e.g., a horn-shaped cup or holder, an irrigation bottle, or a device shaped like a tea pot with a bulbous tipped spout) used to apply a liquid treatment, usually a saline solution, directly to the nasal cavity via the nares, typically to clear and clean the mucous membrane and the nasal channels. Typically made of plastic or as a crockery vessel, the device may include a lid and separate base. It may be known as a nose horn because of its design or a Neti pot and is intended for home-use. This is a reusable device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
543014978
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
16971919462528Medi Grade2L2025-12-29
16971919462535Medi Grade60ml2025-12-29
16971919460500Medi Grade20ML2025-11-20
16971919460494Medi Grade90ml2025-11-17
16971919460432Medi Grade75ml2025-11-11
06971919466949noneER813B2023-10-26
06971919462156noneIBS0012025-03-14
06971919460602BieglerJR60010002024-05-24
06971919460619BieglerJR60030002024-05-24
06971919460626BieglerJR50502012024-05-24
06971919460633BieglerJR60602012024-05-24
06971919460657BieglerJR50503012024-05-24
06971919460664BieglerJR60603012024-05-24
06971919461395PREMIUM2L2024-03-11
06971919461401PREMIUM2L2024-03-11
06971919460725ClarifloRU1000PGS2023-04-20
06971919460732ClarifloRU3000PGS2023-04-20
09369998205660Migraine stopper1.02023-05-31
06971919466253Migraine StopperA/02022-08-09
06971919460336BieglerJR50005002023-06-07

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00850079671058NavägeRhinosystems, Inc.KMA2026-06-09
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
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
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