SPO2 MASIMOSET POD SET KAPPA

GUDID 04049098004961

DRAEGER MEDICAL SYSTEMS, INC.

Patient monitoring system module, pulse oximetry
Primary Device ID04049098004961
NIH Device Record Key6f60861c-d338-4002-897d-524f94214313
Commercial Distribution StatusIn Commercial Distribution
Brand NameSPO2 MASIMOSET POD SET KAPPA
Version Model NumberMS16902
Company DUNS788289952
Company NameDRAEGER MEDICAL SYSTEMS, INC.
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 Perscriptionfalse
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+18004372437
Emailinfo@draeger.com

Device Identifiers

Device Issuing AgencyDevice ID
GS104049098004961 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

DQAOximeter

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 Date2015-10-24

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