FDA.reportPublic FDA data

Portex

Primary DI
55019315107199
Brand
Portex
Company
Smiths Medical Czech Republic a.s.
Model
100/897/070CZ
Published
2016-04-04
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
35019315107195PackageGS11In Commercial Distribution
55019315107199PackageGS17In Commercial Distribution
15019315107191PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
3501931510719535019315107195
5501931510719955019315107199
1501931510719115019315107191

GMDN Terms#

Term, Definition table
TermDefinition
Reinforced tracheostomy tube, single-useA sterile, armoured, hollow cylinder that is inserted into an artificial opening made in the trachea (windpipe) during a tracheotomy to provide a patent airway; typically for a patient with unusual neck mass. It is constructed of plastic with wire reinforcement to provide additional resistance to kinking and may include an inner cannula. It is available in cuffed, uncuffed versions, and in a variety of sizes to meet the individual needs of the patient. It is typically secured in position by a tracheostomy tube holder fastened around the patient's neck. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
361330253
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
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
35019315107287Portex100/386/010CZ2020-06-22
35019315104835Portex100/870/060CZ2020-03-12
55019315104846Portex100/870/070CZ2020-03-12
35019315104859Portex100/870/075CZ2020-03-12
35019315104866Portex100/870/080CZ2020-03-12
35019315104873Portex100/870/085CZ2020-03-12
35019315104880Portex100/870/090CZ2020-03-12
55019315103016Portex100/597/070CZ2016-04-04
55019315106604Portex100/541/080CZ2016-04-04
35019315106617Portex100/541/090CZ2016-04-04
35019315106662Portex100/541/070CZ2016-04-04
35019315106754Portex100/562/000CZ2016-04-04
55019315107144Portex100/597/080CZ2016-04-04
55019315106888Portex100/891/080CZ2016-04-04
35019315106891Portex100/891/090CZ2016-04-04
35019315106907Portex100/892/200CZ2016-04-05
35019315107157Portex100/597/090CZ2016-04-04
35019315107201Portex100/897/080CZ2016-04-04
55019315107229Portex100/899/070CZ2016-04-04
55019315107236Portex100/899/080CZ2016-04-04

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
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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