INFINITY MCABLE-MASIMO SET

GUDID 04049098049672

DRAEGER MEDICAL SYSTEMS, INC.

Single-patient intensive/general healthcare physiologic monitoring system
Primary Device ID04049098049672
NIH Device Record Keye47df241-00dd-439a-9fe0-35b8f460c98f
Commercial Distribution StatusIn Commercial Distribution
Brand NameINFINITY MCABLE-MASIMO SET
Version Model NumberMS20667
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 Batchfalse
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
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
GS104049098049672 [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 Number4
Public Version Date2020-02-06
Device Publish Date2015-10-24

Devices Manufactured by DRAEGER MEDICAL SYSTEMS, INC.

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04048675777762 - Gateway Software Server VF9.1.22025-02-27
04048675780212 - Infinity R50-S Recorder2025-02-27
04049098001519 - Infinity M300 Bedside Charger2025-02-27
04049098007061 - Infinity Gateway USB Dongle2025-02-27
04049098095730 - Infinity M300+2025-02-27
04049098095778 - SHIP UNIT M300+2025-02-27

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