Infinity M540

GUDID 04049098009751

DRAEGER MEDICAL SYSTEMS, INC.

Single-patient intensive/general healthcare physiologic monitoring system General-purpose multi-parameter bedside monitor General-purpose multi-parameter bedside monitor General-purpose multi-parameter bedside monitor General-purpose multi-parameter bedside monitor General-purpose multi-parameter bedside monitor General-purpose multi-parameter bedside monitor General-purpose multi-parameter bedside monitor General-purpose multi-parameter bedside monitor General-purpose multi-parameter bedside monitor General-purpose multi-parameter bedside monitor General-purpose multi-parameter bedside monitor General-purpose multi-parameter bedside monitor General-purpose multi-parameter bedside monitor General-purpose multi-parameter bedside monitor General-purpose multi-parameter bedside monitor General-purpose multi-parameter bedside monitor General-purpose multi-parameter bedside monitor General-purpose multi-parameter bedside monitor
Primary Device ID04049098009751
NIH Device Record Key2ea42678-4fa8-480a-9682-ade0f5a28f34
Commercial Distribution StatusIn Commercial Distribution
Brand NameInfinity M540
Version Model NumberMS26372
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 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
GS104049098009751 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MSXSystem,Network And Communication,Physiological Monitors

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.

04049098099042 - Babyroo TN300 Infant Radiant Warmer2023-06-16
04049098002035 - INFINITY M300 Nellcor WPA2 2020-02-06
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

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