BIONIX DEVELOPMENT CORPORATION 1105

GUDID 00859911004368

Sample- Swaddler for PhotoTherapy, normal

BIONIX DEVELOPMENT CORPORATION

Blanket/pad infant phototherapy unit
Primary Device ID00859911004368
NIH Device Record Key63136f05-c0f4-46d4-a927-7f788b3716d1
Commercial Distribution StatusIn Commercial Distribution
Brand NameBIONIX DEVELOPMENT CORPORATION
Version Model NumberSP-21105
Catalog Number1105
Company DUNS602736795
Company NameBIONIX DEVELOPMENT CORPORATION
Device Count1
DM Exempttrue
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptionfalse
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(800)551-7096
Emailxxx@xxx.xxx
Phone+1(800)551-7096
Emailxxx@xxx.xxx
Phone+1(800)551-7096
Emailxxx@xxx.xxx
Phone+1(800)551-7096
Emailxxx@xxx.xxx
Phone+1(800)551-7096
Emailxxx@xxx.xxx
Phone+1(800)551-7096
Emailxxx@xxx.xxx
Phone+1(800)551-7096
Emailxxx@xxx.xxx
Phone+1(800)551-7096
Emailxxx@xxx.xxx
Phone+1(800)551-7096
Emailxxx@xxx.xxx
Phone+1(800)551-7096
Emailxxx@xxx.xxx
Phone+1(800)551-7096
Emailxxx@xxx.xxx
Phone+1(800)551-7096
Emailxxx@xxx.xxx
Phone+1(800)551-7096
Emailxxx@xxx.xxx
Phone+1(800)551-7096
Emailxxx@xxx.xxx
Phone+1(800)551-7096
Emailxxx@xxx.xxx
Phone+1(800)551-7096
Emailxxx@xxx.xxx
Phone+1(800)551-7096
Emailxxx@xxx.xxx
Phone+1(800)551-7096
Emailxxx@xxx.xxx
Phone+1(800)551-7096
Emailxxx@xxx.xxx
Phone+1(800)551-7096
Emailxxx@xxx.xxx
Phone+1(800)551-7096
Emailxxx@xxx.xxx
Phone+1(800)551-7096
Emailxxx@xxx.xxx
Phone+1(800)551-7096
Emailxxx@xxx.xxx
Phone+1(800)551-7096
Emailxxx@xxx.xxx
Phone+1(800)551-7096
Emailxxx@xxx.xxx
Phone+1(800)551-7096
Emailxxx@xxx.xxx
Phone+1(800)551-7096
Emailxxx@xxx.xxx
Phone+1(800)551-7096
Emailxxx@xxx.xxx
Phone+1(800)551-7096
Emailxxx@xxx.xxx
Phone+1(800)551-7096
Emailxxx@xxx.xxx
Phone+1(800)551-7096
Emailxxx@xxx.xxx
Phone+1(800)551-7096
Emailxxx@xxx.xxx
Phone+1(800)551-7096
Emailxxx@xxx.xxx
Phone+1(800)551-7096
Emailxxx@xxx.xxx
Phone+1(800)551-7096
Emailxxx@xxx.xxx
Phone+1(800)551-7096
Emailxxx@xxx.xxx
Phone+1(800)551-7096
Emailxxx@xxx.xxx
Phone+1(800)551-7096
Emailxxx@xxx.xxx
Phone+1(800)551-7096
Emailxxx@xxx.xxx
Phone+1(800)551-7096
Emailxxx@xxx.xxx
Phone+1(800)551-7096
Emailxxx@xxx.xxx
Phone+1(800)551-7096
Emailxxx@xxx.xxx
Phone+1(800)551-7096
Emailxxx@xxx.xxx
Phone+1(800)551-7096
Emailxxx@xxx.xxx
Phone+1(800)551-7096
Emailxxx@xxx.xxx
Phone+1(800)551-7096
Emailxxx@xxx.xxx
Phone+1(800)551-7096
Emailxxx@xxx.xxx
Phone+1(800)551-7096
Emailxxx@xxx.xxx
Phone+1(800)551-7096
Emailxxx@xxx.xxx
Phone+1(800)551-7096
Emailxxx@xxx.xxx
Phone+1(800)551-7096
Emailxxx@xxx.xxx
Phone+1(800)551-7096
Emailxxx@xxx.xxx

Device Identifiers

Device Issuing AgencyDevice ID
GS100859911004368 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

PDHblanket, neonatal phototherapy

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2017-02-22

On-Brand Devices [BIONIX DEVELOPMENT CORPORATION]

00859911004405DeClogger Starter Pack
00859911004399Wound Irrigation System
00859911004382Wound Irrigation- 25ct
00859911004375Wound Irrigation- 50ct
00859911004368Sample- Swaddler for PhotoTherapy, normal
00859911004351Sample- Swaddler for PhotoTherapy, preemie
00859911004344Sample- DeClogger 18-24 F/Orange
00859911004337Sample-DeClogger 14-16 F/Brown
00859911004320Sample- DeClogger 20-22 F/Green
00859911004313Sample-DeClogger 16-18 F/Yellow
00859911004306Sample-DeClogger 14-16 F/Blue
00859911004214Box of 20 OtoClear Tips
00859911004207Disposable Speculum-20 count
00859911004191Disposable Speculum-48 count
00859911004184Box of 3 Ear Basins
00859911004160Box of 40 OtoClear Tips
00859911004153SprayWash Kit
00859911004146Ear Lavage System

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