Disp. humi.chamber f.F&P MR850

GUDID 04048675422464

Drägerwerk AG & Co. KGaA

Ventilator breathing circuit, single-use
Primary Device ID04048675422464
NIH Device Record Key089408fa-2c29-406a-87a1-f156a56dff2b
Commercial Distribution StatusIn Commercial Distribution
Brand NameDisp. humi.chamber f.F&P MR850
Version Model NumberMP00234
Company DUNS315578914
Company NameDrägerwerk AG & Co. KGaA
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 Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS104048675422464 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

BTTHumidifier, Respiratory Gas, (Direct Patient Interface)

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2019-11-27
Device Publish Date2019-06-18

Devices Manufactured by Drägerwerk AG & Co. KGaA

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04048675253365 - VentStar Helix dual heated2019-11-27
04048675253358 - AutoFeed Chamber2019-11-27
04048675252023 - VentStar Anesthesia Basic 2502019-11-27
04048675252016 - VentStar Anesthesia Basic 1802019-11-27
04048675251903 - VentStar Basic(P)2502019-11-27
04048675251538 - VentStar Anesth WT(P) 180 w/oLL2019-11-27
04048675251521 - VentStar Anesthesia WT (P)1802019-11-27

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