SpO2 Unit(Nellcor) 61626

GUDID 04942962616263

ATOM MEDICAL CORPORATION

Open infant incubator
Primary Device ID04942962616263
NIH Device Record Key36d658aa-f6a8-4252-bc4c-784ee7e06ce3
Commercial Distribution StatusIn Commercial Distribution
Brand NameSpO2 Unit(Nellcor)
Version Model Number61626
Catalog Number61626
Company DUNS690632047
Company NameATOM MEDICAL CORPORATION
Device Count1
DM Exempttrue
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 Perscriptionfalse
OTC Over-The-Counterfalse

Customer Support Contacts

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

Device Identifiers

Device Issuing AgencyDevice ID
GS104942962616263 [Primary]

FDA Product Code

FMTWarmer, Infant Radiant

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

On-Brand Devices [SpO2 Unit(Nellcor)]

0494296261626361626
0494296261622561622

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