FDA.reportPublic FDA data

Portex

Primary DI
15019315061073
Brand
Portex
Company
ICU MEDICAL, INC.
Model
100/905/301
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
35019315061077PackageGS110In Commercial Distribution
15019315061073PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
3501931506107735019315061077
1501931506107315019315061073

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
10887709196923BivonaST26FN85ZSZ174N2026-07-17
10887709196954BivonaFT26FN70NSZ162N2026-07-17
10887709197258BivonaZU26FN70NSC221N2026-07-17
10887709197388BivonaZZ26FN95NSC253N2026-07-17
10887709198149BivonaZU26GN45NGF066N2026-07-17
10887709198637BivonaFU26GN35NSF119N2026-07-17
10887709198644BivonaST26GN60NSC115N2026-07-17
10887709198651BivonaSU26GN60NSC123N2026-07-17
10887709198668BivonaFT26GN35NGE124N2026-07-17
10887709198675BivonaFT26GN30NGE125N2026-07-17
10887709198682BivonaHT26GS95NSC118N2026-07-17
10887709198699BivonaFU26GN45NGF128N2026-07-17
10887709198705BivonaFT26GN40NGE126N2026-07-17
10887709198712BivonaFT26GN35NGE127N2026-07-17
10887709198729BivonaFT26GN40NGF129N2026-07-17
10887709198736BivonaFT26GN60NGA130N2026-07-17
10887709198743BivonaFT26GN40NSE131N2026-07-17
10887709198415BivonaST26GN30NGF103N2026-07-16
10887709198422BivonaST26GN55NSC102N2026-07-16
10887709198439BivonaST26GN45NGF098N2026-07-16

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
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
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
10190752135673N/AAirLife Finland OyBTL2019-04-15
10190752135680N/AAirLife Finland OyBTL2019-04-15
10190752135697N/AAirLife Finland OyBTL2019-04-15
10641043509159Neo-Tee T-Piece Resuscitator CircuitMERCURY ENTERPRISES, INC.BTL2019-01-15