FDA.reportPublic FDA data

Portex

Primary DI
15019315061080
Brand
Portex
Company
ICU MEDICAL, INC.
Model
100/905/302
Published
2020-03-12
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
true
Single use
true

Product Codes#

Code, Name table
CodeName
BTLVentilator, emergency, powered (resuscitator)
BYEAttachment, breathing, positive end expiratory pressure

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
BTLVentilator, Emergency, Powered (Resuscitator)Anesthesiology2
BYEAttachment, Breathing, Positive End Expiratory PressureAnesthesiology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
35019315061084PackageGS110In Commercial Distribution
15019315061080PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
3501931506108435019315061084
1501931506108015019315061080

GMDN Terms#

Term, Definition table
TermDefinition
Ventilator breathing circuit, single-useAn assembly of devices designed to conduct air or oxygen (O2) enriched gases and additional gases [e.g., nitrous oxide (N2O), halogenated gases] from a ventilator to a patient artificial airway/respiratory mask (not included). It includes breathing tubes, a Y-piece connector, and provides connections for devices that humidify, deliver medication, and monitor gas concentration or pressure within the breathing circuit; some types may include a carbon dioxide cuvette and/or an integrated heating wire powered by a connected humidifier intended to warm breathing gases as they enter the patient's airway. This is a single-use device.

Regulatory Flags#

DUNS number
118380146
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10887709206905BivonaFU26JN40NSC136N2026-10-20
10887709206912BivonaFT26JN35NSE138N2026-10-20
10887709206936BivonaFT26JN60NSF126N2026-10-20
10887709206950BivonaFU26JN30NSE134N2026-10-20
10887709206967BivonaFU26JN35NSE135N2026-10-20
10887709206974BivonaFU26JN30NSF137N2026-10-20
10887709206981BivonaFT26JN40NSE142N2026-10-20
10887709206998BivonaFT26JN35NSE143N2026-10-20
10887709207001BivonaSU26JN50NSB144N2026-10-20
10887709206776BivonaFT26JN55NGC127N2026-10-19
10887709206783BivonaXT26JS60NGC132N2026-10-19
10887709206813BivonaXT26JS40NGF130N2026-10-19
10887709206844BivonaFT26JN30NGF129N2026-10-19
10887709206851BivonaFT26JN60NSC131N2026-10-19
10887709206868BivonaFU26JN45NGA115N2026-10-19
10887709206875BivonaFT26JN35NGF133N2026-10-19
10887709206882BivonaSA26JN70NSC097N2026-10-19
10887709206899BivonaFU26HN40NGF206S2026-10-19
10887709206646BivonaSA26JN95NSC113N2026-10-16
10887709206653BivonaHA26JS85NSC114N2026-10-16

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00199972000436CuraplexBOUND TREE MEDICAL, LLCBYE2026-08-15
08437025198559Ventrain®INTERNATIONAL EMERGENCY SERVICES SOCIEDAD LIMITADA.BTL2026-06-24
10641043508473Neo-Tee T-Piece ResuscitatorMERCURY ENTERPRISES, INC.BTL2026-03-26
04048675686712VentStar Resus heated (N)Drägerwerk AG & Co. KGaABTL2025-05-14
04048675686736VentStar AutoBreath heated (N)Drägerwerk AG & Co. KGaABTL2025-05-14
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
10884521831643ShileyCovidien LPBYE2023-02-18
10884521831636ShileyCovidien LPBYE2023-02-16
10637320062004VORTRAN GO2VENT with PEEP ValveVORTRAN MEDICAL TECHNOLOGY 1, INCBTL2021-05-04
10641043574041Flow-Safe II+ BiLevel Disposable CPAP SystemMERCURY ENTERPRISES, INC.BYE2021-01-14
10641043574058Flow-Safe II+ BiLevel Disposable CPAP SystemMERCURY ENTERPRISES, INC.BYE2021-01-14
04054685091408MEDUtriggerWEINMANN Emergency Medical Technology GmbH + Co. KGBTL2020-12-07
10641043572443Flow-Safe II Disposable CPAP SystemMERCURY ENTERPRISES, INC.BYE2020-11-12
10641043572450Flow-Safe II Disposable CPAP SystemMERCURY ENTERPRISES, INC.BYE2020-11-12
10641043572467Flow-Safe II Disposable CPAP SystemMERCURY ENTERPRISES, INC.BYE2020-11-12
10807141000022MOVESThornhill Research IncBTL2020-10-01
10807141000046MOVESThornhill Research IncBTL2020-10-01
00709078008825Disposable PEP DevicesWESTMED, INC.BYE2020-07-31
08498840012130VYGONVygon CorporationBYE2020-03-12
10190752133181AirLife™AIRLIFEBYE2020-01-15
10190752133198AirLife™AIRLIFEBYE2020-01-15
10190752133204AirLife™AIRLIFEBYE2020-01-15
10190752133211AirLife™AIRLIFEBYE2020-01-15
10190752145078AirLife™AIRLIFEBYE2020-01-15
10190752145085AirLife™AIRLIFEBYE2020-01-15
10190752145092AirLife™AIRLIFEBYE2020-01-15
10641043508435Neo-Tee T-Piece ResuscitatorMERCURY ENTERPRISES, INC.BTL2019-10-11
10637320060017VORTRAN GO2VENTVORTRAN MEDICAL TECHNOLOGY 1, INCBTL2019-05-03