BILI-THERAPY Spot Type / Arm Type For F-Rail AC100 60361

GUDID 04942962603614

ATOM MEDICAL CORPORATION

Overhead infant phototherapy unit
Primary Device ID04942962603614
NIH Device Record Key8a618044-7fe7-4869-9c5f-01882b3c9f6a
Commercial Distribution StatusIn Commercial Distribution
Brand NameBILI-THERAPY Spot Type / Arm Type For F-Rail AC100
Version Model Number60361
Catalog Number60361
Company DUNS690632047
Company NameATOM MEDICAL CORPORATION
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 Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+81 488533661
Emailhitoshi.hayashi@atomed.co.jp

Device Dimensions

Height45 Centimeter
Depth13 Centimeter
Width100 Centimeter

Operating and Storage Conditions

Handling Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS104942962603614 [Primary]

FDA Product Code

LBIUnit, Neonatal Phototherapy

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2019-01-29
Device Publish Date2016-09-21

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