FDA.reportPublic FDA data

Portex

Primary DI
55019315016163
Brand
Portex
Company
ICU MEDICAL, INC.
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
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
Tracheostomy tube, non-reinforced, non-customized, single-useA 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 not custom-made for a specific patient and is not reinforced with a wire. 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. It is typically secured in position by a tracheostomy tube holder fastened around the patient's neck. This is a single-use device.

Regulatory Flags#

DUNS number
118380146
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10887709204192BivonaZT26IS70NSC117N2026-09-25
10887709204451BivonaSZ26IN60NSB136S2026-09-25
10887709204734BivonaSU26IN45NSZ100N2026-09-25
10887709204901BivonaFT26IN60NGF183N2026-09-25
10887709204918BivonaFT26IN35NGA182N2026-09-25
10887709204925BivonaSF26IN80NSC186N2026-09-25
10887709204932BivonaSF26IN80NSC185N2026-09-25
10887709204949BivonaFT26IN35NGE187N2026-09-25
10887709204826BivonaFT26IN35NSA181N2026-09-24
10887709204833BivonaFT26IN40NGE170N2026-09-24
10887709204840BivonaFT26IN45NGF169N2026-09-24
10887709204857BivonaFT26IN40NGE179N2026-09-24
10887709204864BivonaFT26IN40NGF172N2026-09-24
10887709204871BivonaFT26IN55NGF171N2026-09-24
10887709204888BivonaHU26IS40NGE177N2026-09-24
10887709204895BivonaHU26IS45NGF178N2026-09-24
10887709204505BivonaFU26IN40NGF143N2026-09-22
10887709204512BivonaFU26IN35NGF144N2026-09-22
10887709204550BivonaFU26IN60NSF145N2026-09-22
10887709204680BivonaFU26IN55NSA164N2026-09-22

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00673693107716Thermo ScientificRICHARD-ALLAN SCIENTIFIC COMPANYNTR2022-06-20
00673693107723Thermo ScientificRICHARD-ALLAN SCIENTIFIC COMPANYNTR2022-06-20
00673693107839Thermo ScientificRICHARD-ALLAN SCIENTIFIC COMPANYNTR2022-06-20
00673693107846Thermo ScientificRICHARD-ALLAN SCIENTIFIC COMPANYNTR2022-06-20
00673693108034Thermo ScientificRICHARD-ALLAN SCIENTIFIC COMPANYNTR2022-06-20
00673693108676Thermo ScientificRICHARD-ALLAN SCIENTIFIC COMPANYNTR2022-06-20
00673693108683Thermo ScientificRICHARD-ALLAN SCIENTIFIC COMPANYNTR2022-06-20
00673693108836Thermo ScientificRICHARD-ALLAN SCIENTIFIC COMPANYNTR2022-06-20
00673693108843Thermo ScientificRICHARD-ALLAN SCIENTIFIC COMPANYNTR2022-06-20
00673693194723Thermo ScientificRICHARD-ALLAN SCIENTIFIC COMPANYNTR2022-06-20
00673693195805Thermo ScientificRICHARD-ALLAN SCIENTIFIC COMPANYNTR2022-06-20
00673693196260Thermo ScientificRICHARD-ALLAN SCIENTIFIC COMPANYNTR2022-06-20
00673693363792Thermo ScientificRICHARD-ALLAN SCIENTIFIC COMPANYNTR2022-06-20
00673693363808Thermo ScientificRICHARD-ALLAN SCIENTIFIC COMPANYNTR2022-06-20
00673693367530Thermo ScientificRICHARD-ALLAN SCIENTIFIC COMPANYNTR2022-06-20
00673693367547Thermo ScientificRICHARD-ALLAN SCIENTIFIC COMPANYNTR2022-06-20
00673693367554Thermo ScientificRICHARD-ALLAN SCIENTIFIC COMPANYNTR2022-06-20
00673693367561Thermo ScientificRICHARD-ALLAN SCIENTIFIC COMPANYNTR2022-06-20
00673693373982Thermo ScientificRICHARD-ALLAN SCIENTIFIC COMPANYNTR2022-06-20
00673693376419Thermo ScientificRICHARD-ALLAN SCIENTIFIC COMPANYNTR2022-06-20
00673693376426Thermo ScientificRICHARD-ALLAN SCIENTIFIC COMPANYNTR2022-06-20
00673693386463Thermo ScientificRICHARD-ALLAN SCIENTIFIC COMPANYNTR2022-06-20
00673693386937Thermo ScientificRICHARD-ALLAN SCIENTIFIC COMPANYNTR2022-06-20
00673693386944Thermo ScientificRICHARD-ALLAN SCIENTIFIC COMPANYNTR2022-06-20
00673693559195Thermo ScientificRICHARD-ALLAN SCIENTIFIC COMPANYNTR2022-06-20
00673693559560Thermo ScientificRICHARD-ALLAN SCIENTIFIC COMPANYNTR2022-06-20
00673693180375Thermo Scientific RICHARD-ALLAN SCIENTIFIC COMPANYNTR2018-04-09
00673693180382Thermo Scientific RICHARD-ALLAN SCIENTIFIC COMPANYNTR2018-04-09
00673693180399Thermo Scientific RICHARD-ALLAN SCIENTIFIC COMPANYNTR2018-04-09
00673693180405Thermo Scientific RICHARD-ALLAN SCIENTIFIC COMPANYNTR2018-04-09