FDA.reportPublic FDA data

Portex

Primary DI
35019315107287
Brand
Portex
Company
Smiths Medical Czech Republic a.s.
Model
100/386/010CZ
Published
2020-06-22
Public version status
New
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
35019315107287PackageGS110In Commercial Distribution
55019315107281PackageGS17In Commercial Distribution
15019315107283PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
3501931510728735019315107287
5501931510728155019315107281
1501931510728315019315107283

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
361330253
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
35019315104835Portex100/870/060CZ2020-03-12
55019315104846Portex100/870/070CZ2020-03-12
35019315104859Portex100/870/075CZ2020-03-12
35019315104866Portex100/870/080CZ2020-03-12
35019315104873Portex100/870/085CZ2020-03-12
35019315104880Portex100/870/090CZ2020-03-12
55019315103016Portex100/597/070CZ2016-04-04
55019315106604Portex100/541/080CZ2016-04-04
35019315106617Portex100/541/090CZ2016-04-04
35019315106662Portex100/541/070CZ2016-04-04
35019315106754Portex100/562/000CZ2016-04-04
55019315107144Portex100/597/080CZ2016-04-04
55019315106888Portex100/891/080CZ2016-04-04
35019315106891Portex100/891/090CZ2016-04-04
35019315106907Portex100/892/200CZ2016-04-05
35019315107157Portex100/597/090CZ2016-04-04
55019315107199Portex100/897/070CZ2016-04-04
35019315107201Portex100/897/080CZ2016-04-04
55019315107229Portex100/899/070CZ2016-04-04
55019315107236Portex100/899/080CZ2016-04-04

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04048223120316FilterPajunk GmbH MedizintechnologieBSN2025-04-04
04048223120323FilterPajunk GmbH MedizintechnologieBSN2025-04-04
04048223069585MiniFilter 0,2µmPajunk GmbH MedizintechnologieBSN2025-01-30
04048223048993MiniFilter 0,2µmPajunk GmbH MedizintechnologieBSN2025-01-30
00840178703477ITDTouchpoint Medical, Inc.BSN2024-09-16
05060498301411Dash 6INTERVENE GROUP LIMITEDBSN2024-01-22
05060498301442Dash 6INTERVENE GROUP LIMITEDBSN2024-01-22
05060498301565Dash 6INTERVENE GROUP LIMITEDBSN2024-01-22
05060498301688Dash 6INTERVENE GROUP LIMITEDBSN2024-01-22
05060498306881Dash 6INTERVENE GROUP LIMITEDBSN2024-01-22
05060498306904Dash 6INTERVENE GROUP LIMITEDBSN2024-01-22
05060498306980Dash 6INTERVENE GROUP LIMITEDBSN2024-01-22
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
05060498306911Dash 6INTERVENE GROUP LIMITEDBSN2023-06-02
05060498302227Dash 6INTERVENE GROUP LIMITEDBSN2023-06-02
04048223049877FILTERPajunk GmbH MedizintechnologieBSN2021-04-02
04048223050064FILTERPajunk GmbH MedizintechnologieBSN2021-04-02
14048223031312NiniFilter NRFitPajunk GmbH MedizintechnologieBSN2020-07-22
14048223041793Filter NRFitPajunk GmbH MedizintechnologieBSN2020-07-22
04048223031315NiniFilter NRFitPajunk GmbH MedizintechnologieBSN2020-07-22
04048223041796Filter NRFitPajunk GmbH MedizintechnologieBSN2020-07-22
15019315107283PortexICU MEDICAL, INC.BSN2020-06-22
15019517054651PortexICU MEDICAL, INC.BSN2020-03-09
15019517071368PortexICU MEDICAL, INC.BSN2020-03-09