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
10887709195131BivonaST26FN50NGF055N2026-06-08
10887709195148BivonaFT25LN30NGF157N2026-06-08
10887709195155BivonaFT26FN35NSF050N2026-06-08
10887709195162BivonaHT26FS45NGF051N2026-06-08
10887709195179BivonaFT26FN40NGF053N2026-06-08
10887709195186BivonaFT26FN35NGF054N2026-06-08
10887709195193BivonaFU26FN45NGF049N2026-06-08
10887709195209BivonaFT26FN60NGA046N2026-06-08
10887709195216BivonaFT26FN35NGE057N2026-06-08
10887709195223BivonaFT26FN30NGE056N2026-06-08
10887709195230BivonaFP26FN40NGC058N2026-06-08
10887709195247BivonaFT26FN35NSF059N2026-06-08
10887709195254BivonaFT26FN40NGE063N2026-06-08
10887709195261BivonaXT26FS60NGC064N2026-06-08
10887709195278BivonaFU26FN45NSF052N2026-06-08
10887709194967BivonaFT26FN40NSF031N2026-06-05
10887709194974BivonaFU26FN35NGF035N2026-06-05
10887709194981BivonaFU26FN40NGE036N2026-06-05
10887709194998BivonaXU26FS35NGA037N2026-06-05
10887709195001BivonaXU26FS35NGA038N2026-06-05

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