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
00887709098602ICU Medical, Inc.DS19022026-05-28
10887709194431BivonaFU26EN35NGE188N2026-05-28
10887709194448BivonaFU26EN35NGE189N2026-05-28
10887709194455BivonaXT26ES70NSC190N2026-05-28
10887709194462BivonaSU26EN50NGF192N2026-05-28
10887709194486BivonaFT26EN35NGF193N2026-05-28
10887709194509BivonaFT26EN40NGF194N2026-05-28
10887709194226BivonaFT26EN35NSF182N2026-05-27
10887709194233BivonaFU26EN40NGA184N2026-05-27
10887709194240BivonaFT26EN60NSA185N2026-05-27
10887709194356BivonaFT26EN40NSF186N2026-05-27
00887709008045ICU MedicalB33382017-04-17
10887709194219BivonaFU26EN60NGC168N2026-05-26
10887709194141BivonaFT26EN40NGE171N2026-05-22
10887709194158BivonaSU26EN45NGG172N2026-05-22
10887709194165BivonaFU26EN35NGF174N2026-05-22
10887709194172BivonaFT26EN40NGF176N2026-05-22
10887709194189BivonaSU26EN50NGF175N2026-05-22
10887709194196BivonaFT26EN70NSC177N2026-05-22
10887709194073BivonaHT26ES60NSC163N2026-05-21

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
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
10641043508428Neo-Tee T-Piece ResuscitatorMERCURY ENTERPRISES, INC.BTL2018-10-24
10641043553282Neo-Tee Tubing KitMERCURY ENTERPRISES, INC.BTL2018-09-15