BILI-THERAPY Pad Type 60370

GUDID 04942962603706

ATOM MEDICAL CORPORATION

Blanket/pad infant phototherapy unit
Primary Device ID04942962603706
NIH Device Record Key9e5bbd99-f6c4-4af8-b688-2a92de9b7dfb
Commercial Distribution StatusIn Commercial Distribution
Brand NameBILI-THERAPY Pad Type
Version Model Number60370
Catalog Number60370
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
Phone+81 488533661
Emailhitoshi.hayashi@atomed.co.jp
Phone+81 488533661
Emailhitoshi.hayashi@atomed.co.jp
Phone+81 488533661
Emailhitoshi.hayashi@atomed.co.jp
Phone+81 488533661
Emailhitoshi.hayashi@atomed.co.jp
Phone+81 488533661
Emailhitoshi.hayashi@atomed.co.jp
Phone+81 488533661
Emailhitoshi.hayashi@atomed.co.jp
Phone+81 488533661
Emailhitoshi.hayashi@atomed.co.jp
Phone+81 488533661
Emailhitoshi.hayashi@atomed.co.jp
Phone+81 488533661
Emailhitoshi.hayashi@atomed.co.jp
Phone+81 488533661
Emailhitoshi.hayashi@atomed.co.jp
Phone+81 488533661
Emailhitoshi.hayashi@atomed.co.jp
Phone+81 488533661
Emailhitoshi.hayashi@atomed.co.jp
Phone+81 488533661
Emailhitoshi.hayashi@atomed.co.jp

Device Dimensions

Depth220 Millimeter
Width150 Millimeter
Depth220 Millimeter
Width150 Millimeter
Depth220 Millimeter
Width150 Millimeter
Depth220 Millimeter
Width150 Millimeter
Depth220 Millimeter
Width150 Millimeter
Depth220 Millimeter
Width150 Millimeter
Depth220 Millimeter
Width150 Millimeter
Depth220 Millimeter
Width150 Millimeter
Depth220 Millimeter
Width150 Millimeter
Depth220 Millimeter
Width150 Millimeter
Depth220 Millimeter
Width150 Millimeter
Depth220 Millimeter
Width150 Millimeter
Depth220 Millimeter
Width150 Millimeter
Depth220 Millimeter
Width150 Millimeter

Operating and Storage Conditions

Handling Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Handling Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Handling Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Handling Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Handling Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Handling Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Handling Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Handling Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Handling Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Handling Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Handling Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Handling Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Handling Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Handling Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS104942962603706 [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

Devices Manufactured by ATOM MEDICAL CORPORATION

04942962610858 - V-2200 Infant Incubator 2024-11-06
04942962616102 - Neo-Servo i Atom Infant Incubator Model 1022024-11-06
04942962674065 - V-2100G Advanced Infant Incubator 2024-11-06
04942962261227 - Mattress Sheet for Neo Cot(5 pcs/pkg)2019-01-29
04942962601450 - Face Mask For Neonatal(20 pcs/box)2019-01-29
04942962601467 - Face Mask For Infant(20 pcs/box)2019-01-29
04942962602167 - Infa Lite AC100-240V2019-01-29
04942962602693 - Pneumoclean Electrostatic Filter(5 pcs/pkg)2019-01-29

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.