FDA.reportPublic FDA data

Portex

Primary DI
35019315016169
Brand
Portex
Company
Smiths Medical International Ltd
Model
100/529/100
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

Product Codes#

Code, Name table
CodeName
NTRIMMUNOHISTOCHEMICAL REAGENT, ANTIBODY (MONOCLONAL OR POLYCLONAL) TO P63 PROTEIN IN NUCLEUS OF PROSTATIC BASAL CELLS

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NTRImmunohistochemical Reagent, Antibody (Monoclonal Or Polyclonal) To P63 Protein In Nucleus Of Prostatic Basal CellsHematology1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K962175000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K962175000PORTEX ADJUSTABLE FLANGE TRACHEOSTOMY TUBESmiths Industries Medical Systems, Inc.1997-01-17JOH

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
15019315016165PackageGS110In Commercial Distribution
35019315016169PackageGS12In Commercial Distribution
55019315016163PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1501931501616515019315016165
3501931501616935019315016169
5501931501616355019315016163

GMDN Terms#

Term, Definition table
TermDefinition
Basic tracheostomy tube, single-useA sterile hollow cylinder designed to be inserted into an artificial opening made in the trachea (windpipe) during a tracheotomy to provide a patent airway. It is typically constructed of plastic and may include an inner cannula. It is available in cuffed, uncuffed, and/or fenestrated versions, and in a variety of shapes and 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
215591523
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
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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