FDA.reportPublic FDA data

Portex

Primary DI
10351688067784
Brand
Portex
Company
ICU MEDICAL, INC.
Model
100/572/LIT
Published
2015-09-01
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
JOHTube tracheostomy and tube cuff

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JOHTube Tracheostomy And Tube CuffAnesthesiology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
30351688067788PackageGS110In Commercial Distribution
10351688067784PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
3035168806778830351688067788
1035168806778410351688067784

GMDN Terms#

Term, Definition table
TermDefinition
Tracheostomy kit, single-useA collection of sterile surgical instruments, dressings/swabs, syringe, dilators, tracheostomy tubes and other items intended to be used to create a percutaneous opening in the trachea (tracheotomy) for the insertion of a tracheostomy tube to relieve upper airway obstruction and to facilitate ventilation. This is a single-use device.

Regulatory Flags#

DUNS number
118380146
Device count
1
Kit
true
Lot or batch
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
10887709194431BivonaICU MEDICAL, INC.JOH2026-05-28
10887709194448BivonaICU MEDICAL, INC.JOH2026-05-28
10887709194455BivonaICU MEDICAL, INC.JOH2026-05-28
10887709194462BivonaICU MEDICAL, INC.JOH2026-05-28
10887709194486BivonaICU MEDICAL, INC.JOH2026-05-28
10887709194509BivonaICU MEDICAL, INC.JOH2026-05-28
10887709194226BivonaICU MEDICAL, INC.JOH2026-05-27
10887709194233BivonaICU MEDICAL, INC.JOH2026-05-27
10887709194240BivonaICU MEDICAL, INC.JOH2026-05-27
10887709194356BivonaICU MEDICAL, INC.JOH2026-05-27
10884521177192ShileyCovidien LPJOH2021-10-05
10884521177208ShileyCovidien LPJOH2021-10-05
10884521177215ShileyCovidien LPJOH2021-10-05
10884521177222ShileyCovidien LPJOH2021-10-05
10884521177239ShileyCovidien LPJOH2021-10-05
10884521177178ShileyCovidien LPJOH2021-09-25
10884521177161ShileyCovidien LPJOH2021-09-11
10884521177154ShileyCovidien LPJOH2021-08-27
10884521177185ShileyCovidien LPJOH2021-08-24
10884521103535ShileyCovidien LPJOH2021-01-18
10884521103542ShileyCovidien LPJOH2021-01-18
10884521103559ShileyCovidien LPJOH2021-01-18
10884521103566ShileyCovidien LPJOH2021-01-18
10884521103573ShileyCovidien LPJOH2019-05-16
10884521103580ShileyCovidien LPJOH2019-05-16
10884521103597ShileyCovidien LPJOH2019-05-16
10884521103603ShileyCovidien LPJOH2019-05-16
10884521103450ShileyCovidien LPJOH2019-05-12
10884521103467ShileyCovidien LPJOH2019-05-12
10884521103474ShileyCovidien LPJOH2019-05-12