FDA.reportPublic FDA data

Portex

Primary DI
00351688068135
Brand
Portex
Company
ICU MEDICAL, INC.
Model
100/399/216
Published
2018-01-03
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
BSOCATHETER, CONDUCTION, ANESTHETIC

Product Code Classifications#

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K051524000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K051524000LOCK-IT PLUS REGIONAL ANESTHESIA CATHETER SECUREMENT DEVICE, MODEL 100/399/216Smiths Medical Asd, Inc.2005-07-07BSO

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10351688068132PackageGS150In Commercial Distribution
00351688068135PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1035168806813210351688068132
00351688068135003516880681353516880681350351688068135

GMDN Terms#

Term, Definition table
TermDefinition
Anaesthesia conduction catheter holder, sterileA sterile device in the form of an adhesive backed pad with a locking mechanism that is used to secure an anaesthesia conduction catheter at the skin insertion site to prevent catheter migration. Also known as an epidural securement device. 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
10887709207919BivonaFT26JN30NGF219N2026-10-29
10887709207926BivonaHT26JS70NSC222N2026-10-29
M335400011ICU Medical, INC.400012025-04-28
M335400031ICU Medical, INC.400022025-04-28
10887709207735BivonaHT26JS80NSC205N2026-10-28
10887709207742BivonaFT26JN60NSA203N2026-10-28
10887709207759BivonaST26JN55NSA204N2026-10-28
10887709207766BivonaFT26JN35NGE206N2026-10-28
10887709207773BivonaFP26JN35NSF202N2026-10-28
10887709207780BivonaFT26JN50NGF207N2026-10-28
10887709207797BivonaFT26JN60NSC214N2026-10-28
10887709207803BivonaFT26JN55NGF213N2026-10-28
10887709207810BivonaFT26JN40NSE215N2026-10-28
10887709207827BivonaFT26JN35NGE212N2026-10-28
10887709207834BivonaFT26JN45NGF211N2026-10-28
10887709207841BivonaFT26JN50NGF210N2026-10-28
10887709207858BivonaFT26JN35NGE209N2026-10-28
10887709207865BivonaFT26JN35NGE217N2026-10-28
10887709207872BivonaFT26JN30NGE216N2026-10-28
10887709207285BivonaFU26JN60NGA169N2026-10-27

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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14026704737403ARROWTELEFLEX INCORPORATEDBSO2026-07-30
10801902211405ARROWTELEFLEX INCORPORATEDBSO2026-07-29
10801902221725ARROWTELEFLEX INCORPORATEDBSO2026-06-24
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04048223085066E-Cath® NRFit Tsui®Pajunk GmbH MedizintechnologieBSO2026-06-10
04048223085073E-Cath® Plus NRFit Tsui®Pajunk GmbH MedizintechnologieBSO2026-06-10
04048223085554E-Cath® NRFit Tsui®Pajunk GmbH MedizintechnologieBSO2026-06-10
04048223086087E-Cath® NRFit Tsui®Pajunk GmbH MedizintechnologieBSO2026-06-10
04048223086261E-Cath® NRFit Tsui®Pajunk GmbH MedizintechnologieBSO2026-06-10
10801902155945ARROWTELEFLEX INCORPORATEDBSO2025-03-10
05060498301534Dash 6GBUK GROUP LIMITEDBSO2024-01-22
05060498306959Dash 6GBUK GROUP LIMITEDBSO2023-06-02
10801902189148ARROWTELEFLEX INCORPORATEDBSO2022-11-29
10801902197570ARROWTELEFLEX INCORPORATEDBSO2022-11-09
10801902197587ARROWTELEFLEX INCORPORATEDBSO2022-11-09
10801902197631ARROWTELEFLEX INCORPORATEDBSO2022-11-09
10801902197723ARROWTELEFLEX INCORPORATEDBSO2022-11-09
10801902197730ARROWTELEFLEX INCORPORATEDBSO2022-11-09
10801902200614ARROWTELEFLEX INCORPORATEDBSO2022-11-09
10801902201444ARROWTELEFLEX INCORPORATEDBSO2022-11-09
10801902201468ARROWTELEFLEX INCORPORATEDBSO2022-11-09
10801902192636ARROWTELEFLEX INCORPORATEDBSO2022-11-08
10801902194579ARROWTELEFLEX INCORPORATEDBSO2022-11-08
10801902194586ARROWTELEFLEX INCORPORATEDBSO2022-11-08
10801902207484ARROWTELEFLEX INCORPORATEDBSO2022-09-14
10801902207521ARROWTELEFLEX INCORPORATEDBSO2022-09-14
10801902207545ARROWTELEFLEX INCORPORATEDBSO2022-09-14
10801902207699ARROWTELEFLEX INCORPORATEDBSO2022-09-14
10801902207705ARROWTELEFLEX INCORPORATEDBSO2022-09-14