FDA.reportPublic FDA data

Pneupac

Primary DI
10887709145914
Brand
Pneupac
Company
ICU MEDICAL, INC.
Model
500-A4844/MRI
Device description
GTIN for 500-A4844/MRI, Pole Clamp Assy MRI, 1/EA
Published
2025-12-04
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
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
30887709145918PackageGS15In Commercial Distribution
10887709145914PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
3088770914591830887709145918
1088770914591410887709145914

GMDN Terms#

Term, Definition table
TermDefinition
Portable active medical device mountA device intended to be fixed (e.g., to a healthcare facility wall, ambulance, trolley, floor) to enable easy and secure short-term and/or long-term mounting of a portable active medical device (e.g., an electronic/electromechanical device such as a barcode reader, emergency suction system, humidifier, resuscitator) during use; the parent device is not included. It may be dedicated to mounting a specific parent device, or non-dedicated. It may in addition allow for integration of a power cable, which may be included; it may provide for storage of the device but is not a dedicated storage mount.

Regulatory Flags#

DUNS number
118380146
Device count
1
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10887709204192BivonaZT26IS70NSC117N2026-09-25
10887709204451BivonaSZ26IN60NSB136S2026-09-25
10887709204734BivonaSU26IN45NSZ100N2026-09-25
10887709204901BivonaFT26IN60NGF183N2026-09-25
10887709204918BivonaFT26IN35NGA182N2026-09-25
10887709204925BivonaSF26IN80NSC186N2026-09-25
10887709204932BivonaSF26IN80NSC185N2026-09-25
10887709204949BivonaFT26IN35NGE187N2026-09-25
10887709204826BivonaFT26IN35NSA181N2026-09-24
10887709204833BivonaFT26IN40NGE170N2026-09-24
10887709204840BivonaFT26IN45NGF169N2026-09-24
10887709204857BivonaFT26IN40NGE179N2026-09-24
10887709204864BivonaFT26IN40NGF172N2026-09-24
10887709204871BivonaFT26IN55NGF171N2026-09-24
10887709204888BivonaHU26IS40NGE177N2026-09-24
10887709204895BivonaHU26IS45NGF178N2026-09-24
10887709204505BivonaFU26IN40NGF143N2026-09-22
10887709204512BivonaFU26IN35NGF144N2026-09-22
10887709204550BivonaFU26IN60NSF145N2026-09-22
10887709204680BivonaFU26IN55NSA164N2026-09-22

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
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
04048675686736VentStar AutoBreath 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