VentStar Resuscitaire CEU

GUDID 04048675026600

Drägerwerk AG & Co. KGaA

Ventilator breathing circuit, single-use
Primary Device ID04048675026600
NIH Device Record Key4d8d43af-e63b-4fda-b3c2-5c6a388f933f
Commercial Distribution StatusIn Commercial Distribution
Brand NameVentStar Resuscitaire CEU
Version Model NumberMP00310
Company DUNS315578914
Company NameDrägerwerk AG & Co. KGaA
Device Count25
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Unsafe
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

Customer Support Contacts

Phone+494518820
Email[email protected]

Device Identifiers

Device Issuing AgencyDevice ID
GS104048675026600 [Primary]
GS104048675422358 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

BYEAttachment, Breathing, Positive End Expiratory Pressure

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2019-11-27
Device Publish Date2015-10-24

Devices Manufactured by Drägerwerk AG & Co. KGaA

04048675253372 - VentStar Helix heated2019-11-27
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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