Sample AlphaCleanse® Antimicrobial Wound Care System 25750

GUDID 00714646000828

Sample AlphaCleanse® Antimicrobial Wound Care System

Bionix, LLC

Wound irrigation kit
Primary Device ID00714646000828
NIH Device Record Key419ffd29-9a99-44f2-8e49-85b8b8a0db79
Commercial Distribution StatusIn Commercial Distribution
Brand NameSample AlphaCleanse® Antimicrobial Wound Care System
Version Model NumberSP-25750
Catalog Number25750
Company DUNS117844489
Company NameBionix, LLC
Device Count1
DM Exempttrue
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kittrue
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(800)551-7096
EmailBionix@bionix.com
Phone+1(800)551-7096
EmailBionix@bionix.com
Phone+1(800)551-7096
EmailBionix@bionix.com
Phone+1(800)551-7096
EmailBionix@bionix.com
Phone+1(800)551-7096
EmailBionix@bionix.com
Phone+1(800)551-7096
EmailBionix@bionix.com
Phone+1(800)551-7096
EmailBionix@bionix.com
Phone+1(800)551-7096
EmailBionix@bionix.com
Phone+1(800)551-7096
EmailBionix@bionix.com
Phone+1(800)551-7096
EmailBionix@bionix.com
Phone+1(800)551-7096
EmailBionix@bionix.com
Phone+1(800)551-7096
EmailBionix@bionix.com
Phone+1(800)551-7096
EmailBionix@bionix.com
Phone+1(800)551-7096
EmailBionix@bionix.com
Phone+1(800)551-7096
EmailBionix@bionix.com
Phone+1(800)551-7096
EmailBionix@bionix.com
Phone+1(800)551-7096
EmailBionix@bionix.com
Phone+1(800)551-7096
EmailBionix@bionix.com
Phone+1(800)551-7096
EmailBionix@bionix.com
Phone+1(800)551-7096
EmailBionix@bionix.com
Phone+1(800)551-7096
EmailBionix@bionix.com
Phone+1(800)551-7096
EmailBionix@bionix.com
Phone+1(800)551-7096
EmailBionix@bionix.com
Phone+1(800)551-7096
EmailBionix@bionix.com
Phone+1(800)551-7096
EmailBionix@bionix.com
Phone+1(800)551-7096
EmailBionix@bionix.com
Phone+1(800)551-7096
EmailBionix@bionix.com
Phone+1(800)551-7096
EmailBionix@bionix.com
Phone+1(800)551-7096
EmailBionix@bionix.com
Phone+1(800)551-7096
EmailBionix@bionix.com
Phone+1(800)551-7096
EmailBionix@bionix.com
Phone+1(800)551-7096
EmailBionix@bionix.com
Phone+1(800)551-7096
EmailBionix@bionix.com
Phone+1(800)551-7096
EmailBionix@bionix.com
Phone+1(800)551-7096
EmailBionix@bionix.com
Phone+1(800)551-7096
EmailBionix@bionix.com
Phone+1(800)551-7096
EmailBionix@bionix.com
Phone+1(800)551-7096
EmailBionix@bionix.com
Phone+1(800)551-7096
EmailBionix@bionix.com
Phone+1(800)551-7096
EmailBionix@bionix.com
Phone+1(800)551-7096
EmailBionix@bionix.com
Phone+1(800)551-7096
EmailBionix@bionix.com
Phone+1(800)551-7096
EmailBionix@bionix.com
Phone+1(800)551-7096
EmailBionix@bionix.com
Phone+1(800)551-7096
EmailBionix@bionix.com
Phone+1(800)551-7096
EmailBionix@bionix.com
Phone+1(800)551-7096
EmailBionix@bionix.com
Phone+1(800)551-7096
EmailBionix@bionix.com
Phone+1(800)551-7096
EmailBionix@bionix.com

Device Dimensions

Total Volume8 Fluid Ounce
Total Volume8 Fluid Ounce
Total Volume8 Fluid Ounce
Total Volume8 Fluid Ounce
Total Volume8 Fluid Ounce
Total Volume8 Fluid Ounce
Total Volume8 Fluid Ounce
Total Volume8 Fluid Ounce
Total Volume8 Fluid Ounce
Total Volume8 Fluid Ounce
Total Volume8 Fluid Ounce
Total Volume8 Fluid Ounce
Total Volume8 Fluid Ounce
Total Volume8 Fluid Ounce
Total Volume8 Fluid Ounce
Total Volume8 Fluid Ounce
Total Volume8 Fluid Ounce

Operating and Storage Conditions

Special Storage Condition, SpecifyBetween 0 and 0 *Room temperature away from direct sunlight, do not freeze
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Room temperature away from direct sunlight, do not freeze
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Room temperature away from direct sunlight, do not freeze
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Room temperature away from direct sunlight, do not freeze
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Room temperature away from direct sunlight, do not freeze
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Room temperature away from direct sunlight, do not freeze
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Room temperature away from direct sunlight, do not freeze
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Room temperature away from direct sunlight, do not freeze
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Room temperature away from direct sunlight, do not freeze
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Room temperature away from direct sunlight, do not freeze
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Room temperature away from direct sunlight, do not freeze
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Room temperature away from direct sunlight, do not freeze
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Room temperature away from direct sunlight, do not freeze
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Room temperature away from direct sunlight, do not freeze
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Room temperature away from direct sunlight, do not freeze
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Room temperature away from direct sunlight, do not freeze
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Room temperature away from direct sunlight, do not freeze
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 77 Degrees Fahrenheit

Device Identifiers

Device Issuing AgencyDevice ID
GS100714646000828 [Primary]

FDA Product Code

FQHLAVAGE, JET

Sterilization

Steralize Prior To Usetrue
Device Is Steriletrue

[00714646000828]

Radiation Sterilization


[00714646000828]

Radiation Sterilization


[00714646000828]

Radiation Sterilization


[00714646000828]

Radiation Sterilization


[00714646000828]

Radiation Sterilization


[00714646000828]

Radiation Sterilization


[00714646000828]

Radiation Sterilization


[00714646000828]

Radiation Sterilization


[00714646000828]

Radiation Sterilization


[00714646000828]

Radiation Sterilization


[00714646000828]

Radiation Sterilization


[00714646000828]

Radiation Sterilization


[00714646000828]

Radiation Sterilization


[00714646000828]

Radiation Sterilization


[00714646000828]

Radiation Sterilization


[00714646000828]

Radiation Sterilization


[00714646000828]

Radiation Sterilization


[00714646000828]

Radiation Sterilization


[00714646000828]

Radiation Sterilization


[00714646000828]

Radiation Sterilization


[00714646000828]

Radiation Sterilization


[00714646000828]

Radiation Sterilization


[00714646000828]

Radiation Sterilization


[00714646000828]

Radiation Sterilization


[00714646000828]

Radiation Sterilization


[00714646000828]

Radiation Sterilization


[00714646000828]

Radiation Sterilization


[00714646000828]

Radiation Sterilization


[00714646000828]

Radiation Sterilization


[00714646000828]

Radiation Sterilization


[00714646000828]

Radiation Sterilization


[00714646000828]

Radiation Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2023-06-19
Device Publish Date2022-10-27

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10714646000566 - Sample, Safe Ear Curette Rainbow Pack2024-07-18 Sample, Safe Ear Curette Rainbow Pack
10714646000641 - Lighted Ear Curette Demo Pack (monthly mailer)2024-07-18 Lighted Ear Curette Demo Pack (monthly mailer)
00714646001085 - Sample, Lighted Suction Handle2024-07-18 Sample, Lighted Suction Handle
00714646001252 - Lighted Articulating - Sample2024-06-24 Lighted Articulating Curette - Sample
10714646001198 - SecureFoam2024-06-10 SecureFoam - Small
10714646001204 - SecureFoam2024-06-10 SecureFoam - Medium

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