Disposable Mechanical Ventilation Circuit

GUDID 04049098041829

DRAEGER MEDICAL SYSTEMS, INC.

Ventilator breathing circuit, single-use
Primary Device ID04049098041829
NIH Device Record Key052b6b05-acc8-415c-85a7-b63ee71b3a32
Commercial Distribution StatusIn Commercial Distribution
Brand NameDisposable Mechanical Ventilation Circuit
Version Model NumberMU04771
Company DUNS788289952
Company NameDRAEGER MEDICAL SYSTEMS, INC.
Device Count20
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latextrue
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS104049098041829 [Unit of Use]
GS104049098061858 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

FPLIncubator, Neonatal Transport

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2025-12-18
Device Publish Date2025-12-10

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