FDA.report

Portex

Primary DI
55019315022386
Brand
Portex
Company
Smiths Medical International Ltd
Model
100/199/100
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

Related Records

Product Codes

CodeName
JOHTube tracheostomy and tube cuff

Product Code Classifications

CodeDeviceSpecialtyClass
JOHTube Tracheostomy And Tube CuffAnesthesiology2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
35019315022382PackageGS120In Commercial Distribution
55019315022386PackageGS16In Commercial Distribution
15019315022388PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalized
3501931502238235019315022382
5501931502238655019315022386
1501931502238815019315022388

GMDN Terms

TermDefinition
Basic endotracheal tube, single-useA hollow cylinder inserted orally or nasally into the trachea to provide an unobstructed airway to convey gases and vapours to and from the lungs during anaesthesia, resuscitation, and other situations where the patient is not properly ventilated. The device may: 1) be packaged with a connector that will attach to a breathing circuit or manual resuscitator; 2) have a distal inflatable cuff to seal against the tracheal wall; 3) be radiopaque; and 4) have a built-in pilot balloon for cuff pressure monitoring. It is typically made of plastic or rubber and is available in various diameters and lengths for adult and paediatric patients. This is a single-use device.

Sterilization Methods

Method

Regulatory Flags

DUNS number
215591523
Device count
1
DM exempt
false
Premarket exempt
true
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 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
10351688003782Portex5120702015-07-29
30351688005896Portex5630902015-07-29
10351688017949Portex5120902015-07-29
10351688018670Portex5120602015-07-29
10351688018809Portex5121002015-07-29
30351688018858Portex5630802015-07-29
10351688036674Portex5120802015-07-29
30351688036715Portex5631002015-07-29
10351688037176Portex5020602015-07-29

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
10887709194219BivonaICU MEDICAL, INC.JOH2026-05-26
10887709194141BivonaICU MEDICAL, INC.JOH2026-05-22
10887709194158BivonaICU MEDICAL, INC.JOH2026-05-22
10887709194165BivonaICU MEDICAL, INC.JOH2026-05-22
10887709194172BivonaICU MEDICAL, INC.JOH2026-05-22
10887709194189BivonaICU MEDICAL, INC.JOH2026-05-22
10887709194196BivonaICU MEDICAL, INC.JOH2026-05-22
10887709188720BivonaICU MEDICAL, INC.JOH2026-03-24
10887709188737BivonaICU MEDICAL, INC.JOH2026-03-24
10887709188744BivonaICU MEDICAL, INC.JOH2026-03-24
10887709188751BivonaICU MEDICAL, INC.JOH2026-03-24
10887709188836BivonaICU MEDICAL, INC.JOH2026-03-24
10887709188843BivonaICU MEDICAL, INC.JOH2026-03-24
10887709188850BivonaICU MEDICAL, INC.JOH2026-03-24
10887709188874BivonaICU MEDICAL, INC.JOH2026-03-24
10887709188881BivonaICU MEDICAL, INC.JOH2026-03-24
10887709188904BivonaICU MEDICAL, INC.JOH2026-03-24
10887709188805BivonaICU MEDICAL, INC.JOH2026-03-23
10887709188812BivonaICU MEDICAL, INC.JOH2026-03-23
10887709188829BivonaICU MEDICAL, INC.JOH2026-03-23
10887709188713BivonaICU MEDICAL, INC.JOH2026-03-22
10887709188768BivonaICU MEDICAL, INC.JOH2026-03-22
10887709187921BivonaICU MEDICAL, INC.JOH2026-03-19
10887709187938BivonaICU MEDICAL, INC.JOH2026-03-19
10887709187945BivonaICU MEDICAL, INC.JOH2026-03-19
10887709188645BivonaICU MEDICAL, INC.JOH2026-03-19
10887709188652BivonaICU MEDICAL, INC.JOH2026-03-19
10887709188669BivonaICU MEDICAL, INC.JOH2026-03-19
10887709188676BivonaICU MEDICAL, INC.JOH2026-03-19
10887709188683BivonaICU MEDICAL, INC.JOH2026-03-19