Infinity Gateway USB Dongle

GUDID 04049098007061

DRAEGER MEDICAL SYSTEMS, INC.

Bedside information system application software
Primary Device ID04049098007061
NIH Device Record Key680e600a-73c2-43a8-ba3f-93b347b622eb
Commercial Distribution StatusIn Commercial Distribution
Brand NameInfinity Gateway USB Dongle
Version Model NumberMS11700
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 Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS104049098007061 [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 StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2025-02-27
Device Publish Date2025-02-19

Devices Manufactured by DRAEGER MEDICAL SYSTEMS, INC.

04048675673408 - Gateway Software Server VF9.0.12025-02-27
04048675762256 - Gateway Software Server VF9.1.12025-02-27
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
04049098007061 - Infinity Gateway USB Dongle2025-02-27
04049098095730 - Infinity M300+2025-02-27
04049098095778 - SHIP UNIT M300+2025-02-27

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