WeeSpecs Infant Eye Protection

GUDID 00850018561273

Phototherapy Mask

INTERNATIONAL BIOMEDICAL, LTD.

Eye mask
Primary Device ID00850018561273
NIH Device Record Keydf00b733-1e30-41e9-8c89-2ea578032329
Commercial Distribution StatusIn Commercial Distribution
Brand NameWeeSpecs Infant Eye Protection
Version Model NumberWeeSpecs
Company DUNS073179368
Company NameINTERNATIONAL BIOMEDICAL, LTD.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone5128730033
Emailsales@int-bio.com
Phone5128730033
Emailsales@int-bio.com
Phone5128730033
Emailsales@int-bio.com
Phone5128730033
Emailsales@int-bio.com
Phone5128730033
Emailsales@int-bio.com
Phone5128730033
Emailsales@int-bio.com
Phone5128730033
Emailsales@int-bio.com
Phone5128730033
Emailsales@int-bio.com
Phone5128730033
Emailsales@int-bio.com
Phone5128730033
Emailsales@int-bio.com
Phone5128730033
Emailsales@int-bio.com
Phone5128730033
Emailsales@int-bio.com
Phone5128730033
Emailsales@int-bio.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100850018561273 [Primary]

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 Date2023-06-29
Device Publish Date2023-06-21

Devices Manufactured by INTERNATIONAL BIOMEDICAL, LTD.

00850018561273 - WeeSpecs Infant Eye Protection2023-06-29Phototherapy Mask
00850018561273 - WeeSpecs Infant Eye Protection2023-06-29 Phototherapy Mask
00850018561099 - Wee Sight Transilluminator 2023-06-28 Wee Sight Transilluminator
00850018561204 - LC Accu-Bar Temperature Trend Indicator2023-06-28 Temperature Trend Indicator
00850018561594 - Infant Heel Warmer2023-06-28 Infant Heel Warmer
00850018561600 - Infant Heel Snuggler2023-06-28 Infant Heel Snuggler
00850018561648 - NeoPod T, Neonatal Transport Humidification System2023-06-28 Neonatal Transport Humidification System
00865648000306 - Aviator Transport Incubator2023-06-28 Aviator Transport Incubator
00865648000313 - NuBorne Infant Warmer2023-06-28 NuBorne Infant Warmer

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