FDA.reportPublic FDA data

Portex

Primary DI
15019315023385
Brand
Portex
Company
SMITHS MEDICAL ASD, INC.
Model
100/386/010
Published
2016-10-11
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
BSNFILTER, CONDUCTION, ANESTHETIC

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
BSNFilter, Conduction, AnestheticAnesthesiology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
35019315023389PackageGS110In Commercial Distribution
55019315023383PackageGS170In Commercial Distribution
15019315023385PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
3501931502338935019315023389
5501931502338355019315023383
1501931502338515019315023385

GMDN Terms#

Term, Definition table
TermDefinition
Anaesthesia conduction filterA sterile microporous membrane used to minimize particulate (foreign material) contamination of a local anaesthetic during administration to a patient (e.g., through an anaesthesia conduction catheter). This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
137835299
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
10887709142029BivonaST24LN70ZSZ142N2025-02-11
10887709141459BivonaFU24LN35NGF086N2025-01-28
10887709139654BivonaZT24KN80NSC005N2025-01-22
10887709136912BivonaZU24JN80NSC259N2025-01-09
10887709141848BivonaST24LN85NSZ127N2025-01-07
10887709142111BivonaZU24LN40NGF133N2025-01-07
10887709142135BivonaFU24LN50NSZ146N2025-01-07
10887709142234BivonaZU24LN30NSE161N2025-01-07
10887709142241BivonaFT24LN50NGC163N2024-12-19
10887709142258BivonaFU24LN40NSA164N2024-12-19
10887709142265BivonaSU24LN60NSB165N2024-12-19
10887709142272BivonaFU24LN35NSF168N2024-12-19
10887709142289BivonaFT24LN55NSF169N2024-12-19
10887709142296BivonaFT24LN40NSE170N2024-12-19
10887709142302BivonaHT24LS55NSA171N2024-12-19
10887709142319BivonaST24LN90NSC124S2024-12-19
10887709142326BivonaFT24LN40NSE166N2024-12-19
10887709142333BivonaSU24LN40NSB167N2024-12-19
10887709142340BivonaHF24LS90NSB174N2024-12-19
10887709142357BivonaFT24LN55NGF172N2024-12-19

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04048223120323FilterPajunk GmbH MedizintechnologieBSN2025-04-04
04048223048993MiniFilter 0,2µmPajunk GmbH MedizintechnologieBSN2025-01-30
00840178703477ITDTouchpoint Medical, Inc.BSN2024-09-16
05060498301435Dash 6INTERVENE GROUP LIMITEDBSN2024-01-22
05060498301459Dash 6INTERVENE GROUP LIMITEDBSN2024-01-22
05060498301572Dash 6INTERVENE GROUP LIMITEDBSN2024-01-22
05060498301695Dash 6INTERVENE GROUP LIMITEDBSN2024-01-22
05060498302289Dash 6INTERVENE GROUP LIMITEDBSN2024-01-22
05060498302265Dash 6INTERVENE GROUP LIMITEDBSN2024-01-22
05060498302104Dash 6INTERVENE GROUP LIMITEDBSN2024-01-22
05060498302227Dash 6INTERVENE GROUP LIMITEDBSN2023-06-02
04048223031315NiniFilter NRFitPajunk GmbH MedizintechnologieBSN2020-07-22
04048223041796Filter NRFitPajunk GmbH MedizintechnologieBSN2020-07-22
35019315107287PortexSmiths Medical Czech Republic a.s.BSN2020-06-22
55019517054659PortexSmiths Medical ASD, Inc.BSN2020-03-09
35019517071393PortexSmiths Medical ASD, Inc.BSN2020-03-09
35019517071416PortexSmiths Medical ASD, Inc.BSN2020-03-09
35019517078767PortexSmiths Medical ASD, Inc.BSN2020-03-09
04054839076251Millex-AAMERCK MILLIPORE LIMITEDBSN2016-09-22
04054839076329Millex-HVMERCK MILLIPORE LIMITEDBSN2016-09-22
04054839076336Millex-ORMERCK MILLIPORE LIMITEDBSN2016-09-22
04054839076343Vented Millex-AAMERCK MILLIPORE LIMITEDBSN2016-09-22
04054839076350Millex-FGMERCK MILLIPORE LIMITEDBSN2016-09-22
04054839076466Millex-FGMERCK MILLIPORE LIMITEDBSN2016-09-22
04054839076480Millex-ORMERCK MILLIPORE LIMITEDBSN2016-09-22
04054839076497Millex-GPMERCK MILLIPORE LIMITEDBSN2016-09-22
04054839076503Millex-GS MERCK MILLIPORE LIMITEDBSN2016-09-22
04054839076510Millex-GSMERCK MILLIPORE LIMITEDBSN2016-09-22
04054839076527Vented Millex-GSMERCK MILLIPORE LIMITEDBSN2016-09-22
04054839076534Millex-GVMERCK MILLIPORE LIMITEDBSN2016-09-22