AlphaCleanse® Antimicrobial Wound Care System 5750

GUDID 00714646000804

AlphaCleanse® Antimicrobial Wound Care System

Bionix, LLC

Wound irrigation kit
Primary Device ID00714646000804
NIH Device Record Keyb12e2884-eb0b-47f2-8d7c-28e19af1808b
Commercial Distribution Discontinuation2024-01-03
Commercial Distribution StatusNot in Commercial Distribution
Brand NameAlphaCleanse® Antimicrobial Wound Care System
Version Model NumberWI-5750
Catalog Number5750
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

Device Identifiers

Device Issuing AgencyDevice ID
GS100714646000804 [Primary]

FDA Product Code

FQHLAVAGE, JET

Sterilization

Steralize Prior To Usetrue
Device Is Steriletrue

[00714646000804]

Radiation Sterilization


[00714646000804]

Radiation Sterilization


[00714646000804]

Radiation Sterilization


[00714646000804]

Radiation Sterilization


[00714646000804]

Radiation Sterilization


[00714646000804]

Radiation Sterilization


[00714646000804]

Radiation Sterilization


[00714646000804]

Radiation Sterilization


[00714646000804]

Radiation Sterilization


[00714646000804]

Radiation Sterilization


[00714646000804]

Radiation Sterilization


[00714646000804]

Radiation Sterilization


[00714646000804]

Radiation Sterilization


[00714646000804]

Radiation Sterilization


[00714646000804]

Radiation Sterilization


[00714646000804]

Radiation Sterilization


[00714646000804]

Radiation Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number5
Public Version Date2024-01-08
Device Publish Date2021-11-18

Devices Manufactured by Bionix, LLC

00714646000606 - Igloo Wound Irrigator2024-10-03 Wound Irrigation - Sample
10714646000665 - ShotBlocker®2024-09-26 5 ct ShotBlocker
10714646000849 - ShotBlocker®2024-09-26 ShotBlocker® 2000 ct. Retail
20714646000860 - SafeStraw™ 2 Pack2024-09-26 SafeStraw™ 2 Pack
10714646000993 - Opti-Tatt™ Dots2024-09-26 Opti-Tatt, Dot, Sheet of 24
10714646001006 - Opti-Tatt™ Crosshairs2024-09-26 Opti-Tatt, Crosshair, Sheet of 24
10714646001013 - Opti-Tatt™ Field Borders2024-09-26 Opti-Tatt, Field Border, Sheet of 24
10714646001020 - Sample: Opti-Tatt Dots2024-09-26 Sample: Opti-Tatt, Dot, Sheet of 3

Trademark Results [AlphaCleanse]

Mark Image

Registration | Serial
Company
Trademark
Application Date
ALPHACLEANSE
ALPHACLEANSE
90546897 not registered Live/Pending
Bionix, LLC
2021-02-25
ALPHACLEANSE
ALPHACLEANSE
90494662 not registered Live/Pending
Bionix Development Corporation
2021-01-28

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