FDA.reportPublic FDA data

Portex

Primary DI
15019517042443
Brand
Portex
Company
ICU MEDICAL, INC.
Model
W1140
Published
2016-04-15
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
BTOTube, tracheostomy (w/wo connector)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
BTOTube, Tracheostomy (W/Wo Connector)Anesthesiology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
35019517042447PackageGS120In Commercial Distribution
15019517042443PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
3501951704244735019517042447
1501951704244315019517042443

GMDN Terms#

Term, Definition table
TermDefinition
Tracheostomy care kit, single-useA collection of sterile devices and supplies intended to be used for the maintenance of a tracheostomy (i.e., removal and cleaning of tracheostomy tube prior to reinsertion). It typically includes towels, gauze, swabs, cleaning brush, and gloves. This is a single-use device.

Regulatory Flags#

DUNS number
118380146
Device count
1
Premarket exempt
true
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
00348783011135Premier Decann StopperPREMIER DENTAL PRODUCTS COMPANYBTO2026-05-27
10192253052893ArgyleCardinal Health 200, LLCBTO2024-07-15
10192253052909ArgyleCardinal Health 200, LLCBTO2024-02-16
10192253052916ArgyleCardinal Health 200, LLCBTO2024-02-16
10192253052923ArgyleCardinal Health 200, LLCBTO2024-02-16
10192253052930ArgyleCardinal Health 200, LLCBTO2024-02-16
10192253052954ArgyleCardinal Health 200, LLCBTO2024-02-16
10192253052978ArgyleCardinal Health 200, LLCBTO2024-02-16
10192253052985ArgyleCardinal Health 200, LLCBTO2024-02-16
10192253052992ArgyleCardinal Health 200, LLCBTO2024-02-16
14063107100571Montgomery® Short-Term CannulaBoston Medical Products, Inc.BTO2022-09-30
14063107100588Montgomery® Long-Term CannulaBoston Medical Products, Inc.BTO2022-09-30
14063107100595Montgomery® Long-Term CannulaBoston Medical Products, Inc.BTO2022-09-30
14063107100601Montgomery® Long-Term CannulaBoston Medical Products, Inc.BTO2022-09-30
14063107100618Montgomery® Long-Term CannulaBoston Medical Products, Inc.BTO2022-09-30
14026704646699RUSCHTELEFLEX INCORPORATEDBTO2019-07-01
14026704646705RUSCHTELEFLEX INCORPORATEDBTO2019-07-01
M6898250001010Mojo RFR First Responder SetSafeguard US Operating, LLCBTO2018-06-04
M6898260001010Mojo RFR Airway & Respiration SetSafeguard US Operating, LLCBTO2018-06-04
10884521751354ShileyCovidien LPBTO2018-02-06
10884521751361ShileyCovidien LPBTO2018-02-06
10381780038542Integra® Miltex®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONBTO2017-10-09
10381780038559Integra® Miltex®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONBTO2017-10-09
10381780038566Integra® Miltex®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONBTO2017-10-09
10381780038573Integra® Miltex®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONBTO2017-10-09
10381780038580Integra® Miltex®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONBTO2017-10-09
10381780038597Integra® Miltex®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONBTO2017-10-09
10381780038603Integra® Miltex®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONBTO2017-10-09
10381780038610Integra® Miltex®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONBTO2017-10-09
10381780038627Integra® Miltex®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONBTO2017-10-09