bionix.comBIONIX DEVELOPMENT CORPORATION - Sample- Swaddler for PhotoTherapy, normal
2017-02-22
BIONIX, LLC
FDA Registration(s)#
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 1526854 | 1526854 | BIONIX, LLC | 1 | Y | 2026-01-01 | 1670 Indianwood Circle Maumee OH US 43537 |
GUDID Contact Samples#
| Source GUDID | Product | Phone | |
|---|---|---|---|
| 00859911004429 | Green MicroLoop® - Curette used for safe cerumen removal | +1(800)551-7096 | Bionix@bionix.com |
| 00859911004436 | Orange ControLoop® - Curette used for safe cerumen removal | +1(800)551-7096 | Bionix@bionix.com |
| 00859911004443 | Red AngleLoop® - Curette used for safe cerumen removal | +1(800)551-7096 | Bionix@bionix.com |
| 00859911004450 | Purple VersaLoop® - Curette used for safe cerumen removal | +1(800)551-7096 | Bionix@bionix.com |
| 00859911004467 | Blue InfantScoop® - Curette used for safe cerumen removal | +1(800)551-7096 | Bionix@bionix.com |
| 00859911004474 | Yellow CeraSpoon® - Curette used for safe cerumen removal | +1(800)551-7096 | Bionix@bionix.com |
| 00859911004481 | White FlexLoop® - Curette used for safe cerumen removal | +1(800)551-7096 | Bionix@bionix.com |
| 00859911004498 | Safe Ear Curette™ Variety Kit - Curette used for safe cerumen removal | +1(800)551-7096 | Bionix@bionix.com |
Registered Device Listings#
| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|---|---|---|---|---|
| 31958 | 1214571502 | K905164 | TUBE DECLOGGER | KNT | 1991-02-13 |
| 31958 | 1315169488 | K180605 | GastroFlush | KNT | 2018-10-24 |
| 31958 | 2040420134 | K153270 | TruGuard Custom Tongue and Jaw Positioner | IYE | 2016-03-08 |
| 31958 | 1644850378 | K123411 | LITTLE ANGELS SWADDLING BLANKET | PDH | 2013-03-07 |
| 31958 | 1697732765 | K120335 | EMBRACE THERMOPLASTIC | IYE | 2012-05-03 |
| 31958 | 1768101202 | K040773 | PELVIS BELLYBOARD PLUS PATIENT POSITIONING SYSTEM | IYE | 2004-04-09 |
| 31958 | 1002996502 | ||||
| 31958 | 1089961473 | ||||
| 31958 | 1203543261 | ||||
| 31958 | 1728811115 | ||||
| 31958 | 1738136016 | ||||
| 31958 | 1915659457 | ||||
| 31958 | 1023390113 | ||||
| 31958 | 1094130206 | ||||
| 31958 | 1125524793 | ||||
| 31958 | 1148877541 | ||||
| 31958 | 1290526944 | ||||
| 31958 | 1307213155 | ||||
| 31958 | 1466245351 | ||||
| 31958 | 1532202039 | ||||
| 31958 | 1600834014 | ||||
| 31958 | 1787433246 | ||||
| 31958 | 1878852580 | ||||
| 31958 | 1917768119 | ||||
| 31958 | 1961396827 | ||||
| 31958 | 1999344086 | ||||
| 31958 | 2053801619 |
Product Codes Associated With Registrations#
GUDID#
ShotBlocker - ShotBlocker 1,000 ct
2024-03-15
ShotBlocker - ShotBlocker 1,000 ct
2024-03-15
AlphaCleanse® Antimicrobial Wound Care System - WI-5750
2021-11-18
AlphaCleanse - Sample, AlphaCleanse Antimicrobial Wound Care System
2022-10-27
DeClogger - DeClogger: Yellow 16-18 French
2017-02-01
Blue DeClogger® - 911
2017-02-01
Green DeClogger® - 913
2017-02-01
Brown DeClogger® - 921
2017-02-01
Orange DeClogger® - 922
2017-02-01
DeClogger - DeClogger Starter Kit
2017-03-07
ShotBlocker® - ShotBlocker 50ct
2021-12-16
ShotBlocker® - ShotBlocker 100ct
2021-12-16
ShotBlocker® - ShotBlocker 50ct
2021-12-16
ShotBlocker® - ShotBlocker 100ct
2021-12-16
AfterSwim - Sample, AfterSwim Water Removal
2023-07-19
AfterSwim - AfterSwim Water Removal
2023-07-19
AfterSwim® Water Removal - AfterSwim Water Removal
2022-01-06
Igloo® Wound Irrigation OTC - Wound Irrigation
2022-07-14
ShotBlocker® - ShotBlocker 1 ct
2021-12-16
BIONIX DEVELOPMENT CORPORATION - Wound Irrigation System
2017-03-06
ClearLook Lighted AngleLoop - ClearLook Lighted AngleLoop, 50 curettes
2023-08-12
ClearLook Lighted MicroLoop - ClearLook Lighted MicroLoop, 50 curettes
2023-08-12
ClearLook Lighted InfantScoop - ClearLook Lighted InfantScoop, 50 curettes
2023-08-12
Clearlook Lighted Variety Pack - Clearlook Lighted Variety Pack, 50 curettes
2023-08-12
ClearLook Lighted AngleLoop - ClearLook Lighted AngleLoop, 50 curettes
2023-08-12
ClearLook Lighted MicroLoop - ClearLook Lighted MicroLoop, 50 curettes
2023-08-12
Clearlook Lighted Variety Pack - Clearlook Lighted Variety Pack, 50 curettes
2023-08-12
ClearLook Lighted InfantScoop - ClearLook Lighted InfantScoop, 50 curettes
2023-08-12
OtoClear Ear Irrigation System Wands - Ear Irrigation System Adapter Wands, 3 ct
2023-07-21
OtoClear Ear Irrigation Tips - OtoClear Tips, 5000 ct
2023-07-21
OtoClear Ear Irrigation System Wands - Ear Irrigation System Adapter Wands, 3 ct
2023-07-21
OtoClear Ear Irrigation Tips - OtoClear Tips, 5000 ct
2023-07-21
OtoClear SprayWash Adapter Wand - SprayWash Adapter Wand
2023-07-21
OtoClear AquaBot Adapter Wand - AquaBot Adapter Wand
2023-07-21
SafeStraw - SafeStraw, Thin Liquids - 12 ct
2023-07-19
SafeStraw - SafeStraw, Thick Liquids - 12 ct
2023-07-19
Preemie Transport Blanket - Preemie Transport Blanket, Very Low Birth Weight Blankets - 15ct
2023-07-19
Preemie Transport Blanket - Preemie Transport Blanket, Low Birth Weight Blankets - 15ct
2023-07-19
AfterSwim - Sample, AfterSwim Water Removal
2023-07-19