Portex

Primary DI
35019315106754
Brand
Portex
Company
Smiths Medical Czech Republic a.s.
Model
100/562/000CZ
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
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
35019315106754PackageGS11In Commercial Distribution
55019315106758PackageGS110In Commercial Distribution
15019315106750PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
3501931510675435019315106754
5501931510675855019315106758
1501931510675015019315106750

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
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
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
55019315107199Portex100/897/070CZ2016-04-04
35019315107201Portex100/897/080CZ2016-04-04
55019315107229Portex100/899/070CZ2016-04-04
55019315107236Portex100/899/080CZ2016-04-04

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