Bili-Bonnet 01B

GUDID 10815090010016

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

SMALL BEGINNINGS INC

Eye pad
Primary Device ID10815090010016
NIH Device Record Key39e7438a-4a5e-4479-90ef-45f4e06c5d53
Commercial Distribution StatusIn Commercial Distribution
Brand NameBili-Bonnet
Version Model Number01B
Catalog Number01B
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 Identifiers

Device Issuing AgencyDevice ID
GS100815090010019 [Primary]
GS110815090010016 [Package]
Contains: 00815090010019
Package: BOX [50 Units]
In Commercial Distribution
GS120815090010013 [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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