VentStar AutoBreath heated (N)

GUDID 04048675686743

Drägerwerk AG & Co. KGaA

Ventilator breathing circuit, single-use
Primary Device ID04048675686743
NIH Device Record Key3c9933e1-d8bf-4c1c-8b10-47c15aa96988
Commercial Distribution StatusIn Commercial Distribution
Brand NameVentStar AutoBreath heated (N)
Version Model NumberMP17031
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
GS104048675686736 [Primary]
GS104048675686743 [Package]
Contains: 04048675686736
Package: [10 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

BTLVentilator, Emergency, Powered (Resuscitator)

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2025-05-22
Device Publish Date2025-05-14

Devices Manufactured by Drägerwerk AG & Co. KGaA

04048675686729 - VentStar Resus heated (N)2025-05-22
04048675686743 - VentStar AutoBreath heated (N)2025-05-22
04048675686743 - VentStar AutoBreath heated (N)2025-05-22
04048675125525 - CLIC adapter2025-05-02
04048675379317 - ECG trunk cable,3-lead,Neo2025-04-18
04048675379324 - ECG limb wires, 3-lead, IEC2025-04-18
04048675379331 - ECG limb wires,5-lead,IEC2025-04-18
04048675379348 - ECG trunk cable,3-lead,IEC/AHA2025-04-18
04048675379355 - ECG trunk cable,5-lead,IEC/AHA2025-04-18

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