FDA.reportPublic FDA data

Hydrodebrider™

Primary DI
00763000435905
Brand
Hydrodebrider™
Company
MEDTRONIC XOMED, INC.
Model
1913001
Device description
CONSOLE 1913001 HYDRODEBRIDER
Published
2025-11-22
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

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
00763000435905PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00763000435905007630004359057630004359050763000435905

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.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature-40 Degrees Celsius70 Degrees Celsius
Storage Environment Temperature-40 Degrees Fahrenheit158 Degrees Fahrenheit

Contacts#

Phone, Email table
PhoneEmail
+1(800)633-8766Corporate.UDI@medtronic.com

Regulatory Flags#

DUNS number
835465063
Device count
1
Premarket exempt
true
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00763000945817ApexCut EM187BL4012EM2026-10-24
00763000945824ApexCut EM187BL4040EM2026-10-24
00763000945831ApexCut EM187BL4060EM2026-10-24
00763000945848ApexCut EM187BL2975EM2026-10-24
00763000945855ApexCut EM187BL3590EM2026-10-24
00763000957858ApexCut EM187BL4000LEM2026-10-24
20763000089652SLIDE-ON® ENDOSHEATH®2245012018-07-07
00681490038997N/A13565012017-09-10
00681490040488NA14160002015-06-23
00681490040518NA14160302015-06-23
20681490040604N/A14190202017-10-13
20681490041762NA15140002016-04-30
20681490042424NA15325002015-06-25
20681490069315NA31185302016-04-17
20681490138622BRIDGEMASTER®6003022017-09-09
20681490138646BOOMERANG®6005002017-09-09
20643169232000Alar ™150002017-10-13
00643169553019XPS®1898200TLO2016-05-01
00643169564749VISAO®3334800LO2016-05-01
20613994394525SLIDE-ON®4444012016-04-23

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00850079671102NavägeRhinosystems, Inc.KMA2026-06-10
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
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
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