Oxygen assembly, NIST fitting, male, C2000e

GUDID 04049098000284

DRAEGER MEDICAL SYSTEMS, INC.

Conventional infant incubator
Primary Device ID04049098000284
NIH Device Record Keyb1ee1df7-b72c-4050-b6d8-7d066382af37
Commercial Distribution StatusIn Commercial Distribution
Brand NameOxygen assembly, NIST fitting, male, C2000e
Version Model NumberMU16950
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+494518820
Emailinfo@draeger.com

Device Identifiers

Device Issuing AgencyDevice ID
GS104049098000284 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

CANRegulator, Pressure, Gas Cylinder

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

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
04049098095730 - Infinity M300+2025-02-27
04049098095778 - SHIP UNIT M300+2025-02-27

© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.