FDA.reportPublic FDA data

Portex

Primary DI
35019517042447
Brand
Portex
Company
Smiths Medical International Ltd
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
OTC
false
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 kitA 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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
215591523
Device count
1
DM exempt
false
Premarket exempt
true
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
30351688423256Portex008430M2015-09-01
30351688423270Portex008430T2015-09-01
30351688423287Portex008431T2015-09-01
30351688424277Portex0084352015-09-01
30351688404002Portex0020002016-10-05
35019517223334PortexC45101816D-NL2020-06-12
35019517236679PortexC45101817D-NL2020-09-18
30351688403036Portex0077672016-10-05
30351688410249Portex0022202016-12-28
30351688410355Portex0077602016-10-05
30351688416128Portex0022232016-12-28
30351688005896Portex5630902015-07-29
30351688018858Portex5630802015-07-29
30351688036715Portex5631002015-07-29
30351688041122Portex5260602015-07-29
30351688041139Portex5260702015-07-29
50351688041140Portex5260802015-07-29
30351688041153Portex5260902015-07-29
35019315052617Portex100/856/0752015-09-01
30351688415510Portex225-3524-8042016-10-11

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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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
14063107100625Montgomery® 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
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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