Infinity Kappa Monitor

GUDID 04049098004039

DRAEGER MEDICAL SYSTEMS, INC.

Single-patient intensive/general healthcare physiologic monitoring system
Primary Device ID04049098004039
NIH Device Record Key4b1f142c-ea31-4624-a1a4-ec706d88625f
Commercial Distribution StatusIn Commercial Distribution
Brand NameInfinity Kappa Monitor
Version Model NumberMS18853
Company DUNS788289952
Company NameDRAEGER MEDICAL SYSTEMS, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Unsafe
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+18004372437
Emailinfo@draeger.com
Phone+18004372437
Emailinfo@draeger.com
Phone+18004372437
Emailinfo@draeger.com
Phone+18004372437
Emailinfo@draeger.com
Phone+18004372437
Emailinfo@draeger.com
Phone+18004372437
Emailinfo@draeger.com
Phone+18004372437
Emailinfo@draeger.com
Phone+18004372437
Emailinfo@draeger.com
Phone+18004372437
Emailinfo@draeger.com
Phone+18004372437
Emailinfo@draeger.com
Phone+18004372437
Emailinfo@draeger.com
Phone+18004372437
Emailinfo@draeger.com
Phone+18004372437
Emailinfo@draeger.com
Phone+18004372437
Emailinfo@draeger.com
Phone+18004372437
Emailinfo@draeger.com
Phone+18004372437
Emailinfo@draeger.com
Phone+18004372437
Emailinfo@draeger.com
Phone+18004372437
Emailinfo@draeger.com
Phone+18004372437
Emailinfo@draeger.com

Device Identifiers

Device Issuing AgencyDevice ID
GS104049098004039 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MHXMonitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2020-02-06
Device Publish Date2015-10-24

Devices Manufactured by DRAEGER MEDICAL SYSTEMS, INC.

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04049098002066 - Infinity M300 Masimo WPA2 2020-02-06
04049098002172 - Omega-S Solution2020-02-06
04049098003858 - Infinity Vista XL Monitor2020-02-06
04049098003865 - INFINITY GAMMMA XL2020-02-06
04049098004022 - Vista Monitor2020-02-06
04049098004039 - Infinity Kappa Monitor2020-02-06
04049098004039 - Infinity Kappa Monitor2020-02-06

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