FDA.reportPublic FDA data

Microsuction Replacement Pack

Primary DI
10714646001105
Brand
Microsuction Replacement Pack
Company
Bionix, LLC
Model
2651
Catalog number
LS-02651
Device description
Microsuction Replacement Pack
Published
2025-07-08
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
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
JZFTUBE, EAR SUCTION
KDQBOTTLE, COLLECTION, VACUUM

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JZFTube, Ear SuctionEar, Nose, Throat1
KDQBottle, Collection, VacuumGeneral Hospital2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00714646001108PrimaryGS10
10714646001105Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00714646001108007146460011087146460011080714646001108
1071464600110510714646001105

GMDN Terms#

Term, Definition table
TermDefinition
Ear canal suction handleA noninvasive, non-powered, hand-held device intended to be connected to, and facilitate manipulation of, an appropriate cannula (not included) for suction/removal (aspiration) of debris from the ear canal during an ear/nose/throat (ENT) procedure; it is not intended for irrigation. It is in the form of a cylinder with an inner lumen which may incorporate a side-hole for low-level suction control (e.g., using the thumb); it does not incorporate a switch(es), valve(s) or button(s). It may include connection tubing. This is a single-use device.

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
117844489
Device count
25
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
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
00859911004948OtoClear® 60cc Luer Lock Syringe Kit723572352022-01-07
007146460007432724527245272452024-07-11
007146460007502727527275272752024-07-11
0071464600098927247SP-27247272472022-10-27
00714646001535Lighted Magnetic Foreign Body Removal Tool352535252026-03-03
10714646001532Lighted Magnetic Foreign Body Removal Tool352535252026-03-03
00714646001627Lighted Magnetic Foreign Body Removal Tool352135212026-03-03
00714646001528Lighted Articulating Ear Curettes - Refill251225122025-11-22
00714646001559Rechargeable Light Source360036002025-11-22
00714646001566ClearLook Variety Pack with Rechargeable Light Source364536452025-11-22
00714646001573ClearLook LEC, Sample Pack-Curettes Only23300233002025-11-22
00714646001580ClearLook Variety Pack334533452025-11-22
00714646001597ClearLook CeraSpoon335033502025-11-22
00714646001603ClearLook Variety, 50ct Refill Pack344534452025-11-22
00714646001610ClearLook CeraSpoon, 50ct Refill Pack345034502025-11-22
00859911004160OtoClear Tips720072002017-01-28
00714646001092Lighted Microsuction System2650LS-026502025-07-08
00714646001108Microsuction Replacement Pack2651LS-026512025-07-08
00859911004795Tabletop Waterpik Adapter Wands27210272102024-07-11
00714646000736OtoClear SprayWash System, Single Use Sample27291272912024-07-11

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00190776423827MillenniumAvalign Technologies, Inc.JZF2026-08-26
04054462901975evonosevonos GmbH & Co. KGJZF2026-08-21
04054462901982evonosevonos GmbH & Co. KGJZF2026-08-21
04054462901999evonosevonos GmbH & Co. KGJZF2026-08-21
04054462902002evonosevonos GmbH & Co. KGJZF2026-08-21
04054462902019evonosevonos GmbH & Co. KGJZF2026-08-21
04054462902026evonosevonos GmbH & Co. KGJZF2026-08-21
04054462902033evonosevonos GmbH & Co. KGJZF2026-08-21
04054462902040evonosevonos GmbH & Co. KGJZF2026-08-21
04054462902057evonosevonos GmbH & Co. KGJZF2026-08-21
04054462902064evonosevonos GmbH & Co. KGJZF2026-08-21
04054462902088evonosevonos GmbH & Co. KGJZF2026-08-21
04054462902095evonosevonos GmbH & Co. KGJZF2026-08-21
04054462902101evonosevonos GmbH & Co. KGJZF2026-08-21
04054462902118evonosevonos GmbH & Co. KGJZF2026-08-21
04054462902125evonosevonos GmbH & Co. KGJZF2026-08-21
04054462902132evonosevonos GmbH & Co. KGJZF2026-08-21
04054462902149evonosevonos GmbH & Co. KGJZF2026-08-21
04054462904396evonosevonos GmbH & Co. KGJZF2026-08-21
04054462904402evonosevonos GmbH & Co. KGJZF2026-08-21
04054462904419evonosevonos GmbH & Co. KGJZF2026-08-21
04054462904426evonosevonos GmbH & Co. KGJZF2026-08-21
04054462904433evonosevonos GmbH & Co. KGJZF2026-08-21
04054462904440evonosevonos GmbH & Co. KGJZF2026-08-21
04054462904457evonosevonos GmbH & Co. KGJZF2026-08-21
04054462904471evonosevonos GmbH & Co. KGJZF2026-08-21
04054462904495evonosevonos GmbH & Co. KGJZF2026-08-21
04054462904501evonosevonos GmbH & Co. KGJZF2026-08-21
04054462904518evonosevonos GmbH & Co. KGJZF2026-08-21
04054462904525evonosevonos GmbH & Co. KGJZF2026-08-21