FDA.reportPublic FDA data

VentStar AutoBreath heated (N)

Primary DI
04048675686736
Brand
VentStar AutoBreath heated (N)
Company
Drägerwerk AG & Co. KGaA
Model
MP17031
Published
2025-05-14
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
true

Product Codes#

Code, Name table
CodeName
BTLVentilator, Emergency, Powered (Resuscitator)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
BTLVentilator, Emergency, Powered (Resuscitator)Anesthesiology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04048675686743PackageGS110In Commercial Distribution
04048675686736PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04048675686743040486756867434048675686743
04048675686736040486756867364048675686736

Regulatory Flags#

DUNS number
315578914
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04048675436607Babyleo TN5002M600002024-03-09
04048675826088VentStar Coax GSL 180MP170452026-10-15
04048675826316Anesthesia Set Coax GSL 180MP170472026-10-15
04048675594956Atlan A100 XL86212002026-08-03
04048675594963Atlan A10086211002026-08-03
04048675822363Babyroo TN300MU303002026-07-15
04048675795124Sample Line 2,5m68738502026-07-21
04048675824121Seattle PAPMP022542026-06-11
04048675001065OxyTrace IncuMX010502015-10-24
04048675016403Savina System84144502015-10-24
04048675017097Babytherm 8010 System2M223802015-10-24
04048675017165Caleo2M500002015-10-24
04048675041382Babytherm 8004 System2M223702015-10-24
04048675042174NBP Cuff L+, 31-40/55cm, Box10MP009322022-06-22
04048675251422Savina 30084178002015-10-24
04048675686712VentStar Resus heated (N)MP170302025-05-14
04048675641308Babyleo TN5002M611002026-03-23
04048675379300IBP Cable Utah26064912026-01-07
04048675557722IBP Adapter Cable Dräger 7pin26075582026-01-07
04048675379072IBP cable Becton Dickinson26064882026-01-06

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08437025198559Ventrain®INTERNATIONAL EMERGENCY SERVICES SOCIEDAD LIMITADA.BTL2026-06-24
10641043508473Neo-Tee T-Piece ResuscitatorMERCURY ENTERPRISES, INC.BTL2026-03-26
10887709145907PneupacICU MEDICAL, INC.BTL2025-12-04
10887709145914PneupacICU MEDICAL, INC.BTL2025-12-04
30887709145901PneupacICU MEDICAL, INC.BTL2025-12-04
30887709145918PneupacICU MEDICAL, INC.BTL2025-12-04
M68970110HMU020SAVe II+ Simplified Automated VentilatorSafeguard US Operating, LLCBTL2025-11-20
04048675686712VentStar Resus heated (N)Drägerwerk AG & Co. KGaABTL2025-05-14
04048675686729VentStar Resus heated (N)Drägerwerk AG & Co. KGaABTL2025-05-14
04048675686743VentStar AutoBreath heated (N)Drägerwerk AG & Co. KGaABTL2025-05-14
00850071887242Emergent RespiratoryMDL Solutions IncorporatedBTL2025-04-05
M6892500301010SAVeII+ Starter Bundle, 3-Patient – BasicSafeguard US Operating, LLCBTL2025-02-26
M6892501001010SAVeII+ Starter Bundle, 10-Patient – BasicSafeguard US Operating, LLCBTL2025-02-26
00637320061239VORTRAN GO2VENT® with Peep ValveVORTRAN MEDICAL TECHNOLOGY 1, INCBTL2025-02-20
M68970111HUS010SAVe II+ Simplified Automated VentilatorSafeguard US Operating, LLCBTL2024-12-17
10641043913161Neo-Tee T-Piece Resuscitator CircuitMERCURY ENTERPRISES, INC.BTL2024-02-08
10641043913352Neo-Tee T-Piece Resuscitator CircuitMERCURY ENTERPRISES, INC.BTL2024-02-08
10641043913659Neo-Tee T-Piece Resuscitator CircuitMERCURY ENTERPRISES, INC.BTL2024-02-08
30641043913165Neo-Tee T-Piece Resuscitator CircuitMERCURY ENTERPRISES, INC.BTL2024-02-08
30641043913356Neo-Tee T-Piece Resuscitator CircuitMERCURY ENTERPRISES, INC.BTL2024-02-08
30641043913653Neo-Tee T-Piece Resuscitator CircuitMERCURY ENTERPRISES, INC.BTL2024-02-08
00851629008072SAVe II+Automedx, LLCBTL2024-01-06
10851629008079SAVe II+Automedx, LLCBTL2024-01-06
20851629008076SAVe II+Automedx, LLCBTL2024-01-06
90851629008075SAVe II+Automedx, LLCBTL2024-01-06
07898671250175OXYMAGMAGNAMED TECNOLOGIA MEDICA SABTL2023-12-06
10889483231739VentlabVENTLAB, LLCBTL2023-07-18
10889483231746VentlabVENTLAB, LLCBTL2023-07-18
10889483231760VentlabVENTLAB, LLCBTL2023-07-18
10889483231777VentlabVENTLAB, LLCBTL2023-07-18