FDA.reportPublic FDA data

Portex

Primary DI
30351688067788
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
OTC
false
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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
118380146
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
true
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

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