FDA.reportPublic FDA data

HYDROCLEANSE™

Primary DI
00643169864429
Brand
HYDROCLEANSE™
Company
MEDTRONIC XOMED, INC.
Model
1960100
Device description
DEVICE 1960100 SINUS WASH SYSTEM
Published
2018-08-09
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
KARIRRIGATOR, SINUS

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KARIrrigator, SinusEar, Nose, Throat1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00643169864429PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00643169864429006431698644296431698644290643169864429

GMDN Terms#

Term, Definition table
TermDefinition
Nasal irrigation set, clinicalA collection of sterile items intended to dispense a solution to penetrate, clear, and clean the nasal passages and sinus cavity for the relief of nasal and sinus symptoms (e.g., nasal congestion, sinus pressure, secretions, nasopharyngeal discharge, encrustations, nasal dryness) and/or before, during and/or after ENT surgery. It typically includes an irrigation bottle/canister/syringe which can include a pumping mechanism, actuator tips and adaptors for various solution-delivery applications and connector tubing. This device is intended to be used by a professional in a clinical setting. This is a single-use device.

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
835465063
Device count
1
Premarket exempt
true
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00763000843908NIM VitalNIM4CM012026-08-22
00763000843915NIM VitalNIM4CPB12026-08-22
00199150037407NIM™8225825X2026-03-29
00643169644656Otomag™ Attract™ Magnetic SpacerS0266-002016-04-15
00643169644663Otomag™ Attract™ Magnetic SpacerS0266-012016-04-15
00643169644670Otomag™ Attract™ Magnetic SpacerS0266-022016-04-15
00643169644687Otomag™ Attract™ Magnetic SpacerS0266-032016-04-15
00643169644694Otomag™ Attract™ Magnetic SpacerS0266-042016-04-15
00643169644700Otomag™ Attract™ Magnetic SpacerS0266-052016-04-15
00643169644717Otomag™ Attract™ Magnetic SpacerS0266-062016-04-15
00643169644731Otomag™ Attract™ Magnetic SpacerS0266-082016-04-15
00643169644748Otomag™ Attract™ Magnetic SpacerS0266-092016-04-15
00643169644755Otomag™ Attract™ Magnetic SpacerS0266-102016-04-15
00643169644762Otomag™ Attract™ Magnetic SpacerS0266-112016-04-15
00643169644779Otomag™ Attract™ Magnetic SpacerS0266-152016-04-15
00643169644786Otomag™ Attract™ Magnetic SpacerS0266-212016-04-15
00643169644793Otomag™ Attract™ Magnetic SpacerS0542-002016-04-15
00643169644809Otomag™ Attract™ Magnetic SpacerS0542-012016-04-15
00643169644816Otomag™ Attract™ Magnetic SpacerS0542-022016-04-15
00643169644823Otomag™ Attract™ Magnetic SpacerS0542-032016-04-15

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06978785665117InhwRiorShenzhen Yuechuan trade Co., Ltd.KAR2025-12-08
06978785665124InhwRiorShenzhen Yuechuan trade Co., Ltd.KAR2025-12-08
06978785665148InhwRiorShenzhen Yuechuan trade Co., Ltd.KAR2025-12-08
06978785665056InhwRiorShenzhen Yuechuan trade Co., Ltd.KAR2025-08-08
00194613022020MSI Precision Specialty InstrumentsMed Saver, Inc.KAR2025-08-01
00194613022044MSI Precision Specialty InstrumentsMed Saver, Inc.KAR2025-08-01
00194613022051MSI Precision Specialty InstrumentsMed Saver, Inc.KAR2025-08-01
00194613022068MSI Precision Specialty InstrumentsMed Saver, Inc.KAR2025-08-01
00194613022075MSI Precision Specialty InstrumentsMed Saver, Inc.KAR2025-08-01
00194613022082MSI Precision Specialty InstrumentsMed Saver, Inc.KAR2025-08-01
00805106849603XTREMEXtreme Personal Care Inc.KAR2025-04-20
00194613022006MSI Precision Specialty InstrumentsMed Saver, Inc.KAR2025-03-21
00194613022013MSI Precision Specialty InstrumentsMed Saver, Inc.KAR2025-03-21
00194613022037MSI Precision Specialty InstrumentsMed Saver, Inc.KAR2025-03-21
00194613022099MSI Precision Specialty InstrumentsMed Saver, Inc.KAR2025-03-21
00887482123874Symmetry ASPEN SURGICAL PRODUCTS, INC.KAR2024-08-15
00887482124970Symmetry JacksonASPEN SURGICAL PRODUCTS, INC.KAR2024-08-15
00888515244573BOSS InstrumentsBOSS INSTRUMENTS, LTD., INC.KAR2024-02-28
00888515244597BOSS InstrumentsBOSS INSTRUMENTS, LTD., INC.KAR2024-02-28
00888515251014BOSS InstrumentsBOSS INSTRUMENTS, LTD., INC.KAR2024-02-28
00888515251038BOSS InstrumentsBOSS INSTRUMENTS, LTD., INC.KAR2024-02-28
00888515251045BOSS InstrumentsBOSS INSTRUMENTS, LTD., INC.KAR2024-02-28
00888515251052BOSS InstrumentsBOSS INSTRUMENTS, LTD., INC.KAR2024-02-28
00888515251076BOSS InstrumentsBOSS INSTRUMENTS, LTD., INC.KAR2024-02-28
00888515251120BOSS InstrumentsBOSS INSTRUMENTS, LTD., INC.KAR2024-02-28
00888515251137BOSS InstrumentsBOSS INSTRUMENTS, LTD., INC.KAR2024-02-28
00888515251144BOSS InstrumentsBOSS INSTRUMENTS, LTD., INC.KAR2024-02-28
00888515251151BOSS InstrumentsBOSS INSTRUMENTS, LTD., INC.KAR2024-02-28
00888515251175BOSS InstrumentsBOSS INSTRUMENTS, LTD., INC.KAR2024-02-28
G586E97332590Novo SurgicalNOVO SURGICAL, INC.KAR2023-12-18