A750i Infant Incubator

GUDID 00868406000013

A750i Infant Transport Incubator, with Optional PulseOx

INTERNATIONAL BIOMEDICAL, LTD.

Transport infant incubator
Primary Device ID00868406000013
NIH Device Record Key1b4cc375-0c94-42e8-94b0-e27e492fa2d1
Commercial Distribution StatusIn Commercial Distribution
Brand NameA750i Infant Incubator
Version Model NumberA750i
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 Batchfalse
Serial Numbertrue
Manufacturing Datefalse
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

Device Identifiers

Device Issuing AgencyDevice ID
GS100868406000013 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

FPLIncubator, Neonatal Transport

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 Date2016-09-27

Devices Manufactured by INTERNATIONAL BIOMEDICAL, LTD.

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