FDA.reportPublic FDA data

OtoClear® WaterPik® Kit

Primary DI
00859911004177
Brand
OtoClear® WaterPik® Kit
Company
Bionix, LLC
Model
7245
Catalog number
7245
Device description
Portable WaterPik
Published
2022-01-07
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Contact Domains#

Product Codes#

Code, Name table
CodeName
KCPSYRINGE, ENT

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KCPSyringe, EntEar, Nose, Throat1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00859911004177PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00859911004177008599110041778599110041770859911004177

GMDN Terms#

Term, Definition table
TermDefinition
Ear canal lavage systemA device assembly designed for automated or semi-automated irrigation, washing, and extraction of tissue and/or debris from the ear canal. 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 vacuum extractor, a reservoir for the solution; and a handpiece that may include a set of detachable tips intended for introduction into the ear canal. The system is mainly intended to remove debris (typically cerumen) to clean the ear canal for hygienic purposes, to improve hearing, and before procedures and/or surgery in or through the ear canal.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)551-7096Bionix@bionix.com

Regulatory Flags#

DUNS number
117844489
Device count
1
DM exempt
true
Premarket exempt
true
HCT/P
false
Kit
true
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00714646001153Clearlook Lighted Variety Pack334533452023-08-12
00714646001344ClearLook Lighted Variety Pack, Refill344534452025-02-25
00714646001368ClearLook Lighted Variety Pack with Rechargeable Light Source364536452025-02-25
00714646001375Rechargeable Light Source360036002025-02-25
10714646001532Lighted Magnetic Foreign Body Removal Tool352535252026-03-03
00714646001627Lighted Magnetic Foreign Body Removal Tool352135212026-03-03
00714646000736OtoClear SprayWash System, Single Use Sample27291272912024-07-11
10859911004792Tabletop Waterpik Adapter Wands27210272102024-07-11
00714646001474Pelvis Belly Replacement Leg CushionPPRT-5101PPRT-51012025-08-21
00714646001481Pelvis Belly Replacement Arm Rest CushionPPRT-5103PPRT-51032025-08-21
00714646001498Pelvis Belly Replacement Stomach Cushion - MediumPPRT-5104PPRT-51042025-08-21
00714646001504Pelvis Belly Replacement Face Cushion AssemblyPPRT-5107PPRT-51072025-08-21
00714646001511Pelvis Belly Replacement Stomach Cushion - SmallPPRT-5108PPRT-51082025-08-21
10714646001099Microsuction Stater Pack2650LS-026502025-07-08
10714646001105Microsuction Replacement Pack2651LS-026512025-07-08
10714646001129Sample: Opti-Tatt24100241002025-06-20
00714646001382Prone Breast, Cushion, Contralateral Breast Insert, 15 degree, ReplacementPBRT-6243PBRT-62432025-05-28
00714646001399Prone Breast, Face Cushion, ReplacementPBRT-6253PBRT-62532025-05-28
00714646001405Prone Breast, Arm Rest, ReplacementPBRT-6255PBRT-62552025-05-28
00714646001412Prone Breast, Leg Cushion, ReplacementPBRT-6270PBRT-62702025-05-28

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
16971919460494Medi GradeNingbo Albert Novosino Co.,Ltd.KCP2025-11-17
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00194613021535MSI Precision Specialty InstrumentsMed Saver, Inc.KCP2025-08-01
00194613112639MSI Precision Specialty InstrumentsMed Saver, Inc.KCP2025-08-01
00757770410651Bausch + LombBausch & Lomb IncorporatedKCP2025-07-29
00757770435401Bausch + LombBausch & Lomb IncorporatedKCP2025-07-29
00757770435999Bausch + LombBausch & Lomb IncorporatedKCP2025-07-29
00757770436620Bausch + LombBausch & Lomb IncorporatedKCP2025-07-29
00757770457588Bausch + LombBausch & Lomb IncorporatedKCP2025-07-29
10661392010441LSL HEALTHCARELSL Industries, LLCKCP2025-05-16
10661392010458LSL HEALTHCARELSL Industries, LLCKCP2025-05-16
10661392010809LSL HEALTHCARELSL Industries, LLCKCP2025-05-16
10661392013411LSL HEALTHCARELSL Industries, LLCKCP2025-05-16
10661392045399LSL HEALTHCARELSL Industries, LLCKCP2025-05-16
00370275092025FS Dispenser, StainlessForward Science Technologies LLCKCP2024-10-14
EDET031591mixing cannulas optima lilac 50 pcs.DETAX GmbHKCP2024-08-28
EDET031601mixing cannulas optima lilac 100 pcs.DETAX GmbHKCP2024-08-28
EDET041941mixing cannulas Automix 2 T-Mixer yellow 25 pcsDETAX GmbHKCP2024-08-28
00840183511951BR Surgical, LLCBR Surgical, LLCKCP2024-06-10
00840183511968BR Surgical, LLCBR Surgical, LLCKCP2024-06-10
00840183525477BR Surgical, LLCBR Surgical, LLCKCP2024-06-10
00370275091011FS DispenserForward Science Technologies LLCKCP2024-02-21
EDET034481Flexible tube for minimix cannulas, 20 cmDETAX GmbHKCP2024-02-12
00810132804106House Brand DentistryHouse Brand DentistryKCP2024-01-31
EDET032451bulk box mix.cann.optima lila 2500pcsDETAX GmbHKCP2023-12-21
G586E733516S0Novo SurgicalNOVO SURGICAL, INC.KCP2023-12-18
G586E733518S0Novo SurgicalNOVO SURGICAL, INC.KCP2023-12-18
G586E733521S0Novo SurgicalNOVO SURGICAL, INC.KCP2023-12-18
G586E7335270Novo SurgicalNOVO SURGICAL, INC.KCP2023-12-18
G586E97335200Novo SurgicalNOVO SURGICAL, INC.KCP2023-12-18