Bili-Bonnet 01A

GUDID 10815090010009

Bili-Bonnet Preemie size phototherapy masks to protect infants eyes from phototherapy for treatment of jaundice.

SMALL BEGINNINGS INC

Eye pad
Primary Device ID10815090010009
NIH Device Record Key47344a30-c266-4208-8586-48d0c82b6a0d
Commercial Distribution StatusIn Commercial Distribution
Brand NameBili-Bonnet
Version Model Number01A
Catalog Number01A
Company DUNS002657679
Company NameSMALL BEGINNINGS INC
Device Count1
DM Exemptfalse
Pre-market Exempttrue
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 Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Countertrue

Customer Support Contacts

Phone760-949-7707
Emailkelly@small-beginnings.com
Phone760-949-7707
Emailkelly@small-beginnings.com
Phone760-949-7707
Emailkelly@small-beginnings.com
Phone760-949-7707
Emailkelly@small-beginnings.com
Phone760-949-7707
Emailkelly@small-beginnings.com
Phone760-949-7707
Emailkelly@small-beginnings.com
Phone760-949-7707
Emailkelly@small-beginnings.com
Phone760-949-7707
Emailkelly@small-beginnings.com
Phone760-949-7707
Emailkelly@small-beginnings.com
Phone760-949-7707
Emailkelly@small-beginnings.com
Phone760-949-7707
Emailkelly@small-beginnings.com
Phone760-949-7707
Emailkelly@small-beginnings.com
Phone760-949-7707
Emailkelly@small-beginnings.com
Phone760-949-7707
Emailkelly@small-beginnings.com

Device Dimensions

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Device Identifiers

Device Issuing AgencyDevice ID
GS100815090010002 [Primary]
GS110815090010009 [Package]
Contains: 00815090010002
Package: BOX [50 Units]
In Commercial Distribution
GS120815090010006 [Package]
Package: CASE [4 Units]
In Commercial Distribution

FDA Product Code

FOKPad, Neonatal Eye

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-08-11
Device Publish Date2020-08-03

On-Brand Devices [Bili-Bonnet]

10815090010177Bili-Bonnet Ultra-Preemie size phototherapy masks to protect infants eyes from phototherapy for
10815090010016Bili-Bonnet Newborn size phototherapy masks to protect infants eyes from phototherapy for treatm
10815090010009Bili-Bonnet Preemie size phototherapy masks to protect infants eyes from phototherapy for treatm

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