FDA.reportPublic FDA data

Portex

Primary DI
15019517075809
Brand
Portex
Company
ICU MEDICAL, INC.
Model
24-1013-64
Published
2020-03-09
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
BSPNEEDLE, CONDUCTION, ANESTHETIC (W/WO INTRODUCER)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
BSPNeedle, Conduction, Anesthetic (W/Wo Introducer)Anesthesiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K172823000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K172823000Portex NRFit Epidural NeedlesSmiths Medical Asd, Inc.2018-06-12BSP

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
35019517075803PackageGS120In Commercial Distribution
55019517075807PackageGS110In Commercial Distribution
15019517075809PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
3501951707580335019517075803
5501951707580755019517075807
1501951707580915019517075809

GMDN Terms#

Term, Definition table
TermDefinition
Epidural needle, non-threadedA sterile, sharp bevel-edged, hollow tubular metal instrument designed to access the epidural space. It may be used to deliver anaesthetic or analgesic agents or to introduce a dedicated catheter for continuous anaesthesia administration. If used with a stylet, it is often referred to as a cannula. 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
10887709198033BivonaFT26GN40NGE057N2026-07-13
10887709198040BivonaXA26GS70NSC058N2026-07-13
10887709198057BivonaFT26GN35NGE060N2026-07-13
10887709198071BivonaFT26GN60NSC063N2026-07-13
10887709198088BivonaFT26GN45NGF056N2026-07-13
10887709198125BivonaFT26GN35NSE071N2026-07-13
10887709198132BivonaFT26GN35NSE072N2026-07-13
10887709197814BivonaSU26EN50NSF192S2026-07-10
10887709197821BivonaFT26GN35NSE028N2026-07-10
10887709197913BivonaFU26GN50NGF047N2026-07-10
10887709197920BivonaFU26GN50NGF049N2026-07-10
10887709197944BivonaFT26GN70NSD050N2026-07-10
10887709197951BivonaFU26GN45NGF051N2026-07-10
10887709197968BivonaXT26GS80NSC052N2026-07-10
10887709197975BivonaFT26GN30NGE053N2026-07-10
10887709197982BivonaFT26GN40NGE054N2026-07-10
10887709197999BivonaFA26GN80NSC055N2026-07-10
10887709198002BivonaHU26GS45NSC040N2026-07-10
10887709198019BivonaFT26GN40NSE041N2026-07-10
10887709198026BivonaFU26GN35NGF048N2026-07-10

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04048223139110CauDal SonoPajunk GmbH MedizintechnologieBSP2026-07-06
04048223070499NerveGuard NRFitPajunk GmbH MedizintechnologieBSP2026-06-10
04048223076217Quincke NRFitPajunk GmbH MedizintechnologieBSP2026-06-10
04048223076248Quincke NRFitPajunk GmbH MedizintechnologieBSP2026-06-10
04048223076347Quincke NRFitPajunk GmbH MedizintechnologieBSP2026-06-10
10198459468025MEDLINE INDUSTRIES, INC.MEDLINE INDUSTRIES, INC.BSP2025-08-18
M661S103417350Plastic BD Style Hub Tuohy Epidural NeedleSpectra Medical Devices, LLCBSP2024-06-18
M661S103418350Plastic BD Style Hub Tuohy Epidural NeedleSpectra Medical Devices, LLCBSP2024-06-18
M661S103418500Plastic BD Style Hub Tuohy Epidural NeedleSpectra Medical Devices, LLCBSP2024-06-18
M661S80C21600MSK Ultrasonic Injection NeedleSpectra Medical Devices, LLCBSP2024-06-18
M661S80C22200MSK Ultrasonic Injection NeedleSpectra Medical Devices, LLCBSP2024-06-18
M661S80C23200MSK Ultrasonic Injection NeedleSpectra Medical Devices, LLCBSP2024-06-18
M661S90C22600MSK Ultrasonic Injection NeedleSpectra Medical Devices, LLCBSP2024-06-18
08886479300252Reach NeedleAerin Medical Inc.BSP2024-06-10
M661S80C21200MSK Ultrasonic Injection NeedleSpectra Medical Devices, LLCBSP2024-02-12
M661S80C21400MSK Ultrasonic Injection NeedleSpectra Medical Devices, LLCBSP2024-02-12
00382904003715BD Whitacre SpinalBECTON, DICKINSON AND COMPANYBSP2023-09-02
00382904003722BD Whitacre SpinalBECTON, DICKINSON AND COMPANYBSP2023-09-02
00382904003739BD Whitacre SpinalBECTON, DICKINSON AND COMPANYBSP2023-09-02
00382904003821BD Whitacre SpinalBECTON, DICKINSON AND COMPANYBSP2023-09-02
05060498301626Dash 6GBUK GROUP LIMITEDBSP2023-06-02
05060498301657Dash 6GBUK GROUP LIMITEDBSP2023-06-02
05060498301770Dash 6GBUK GROUP LIMITEDBSP2023-06-02
05060498306898Dash 6GBUK GROUP LIMITEDBSP2023-06-02
05060498306928Dash 6GBUK GROUP LIMITEDBSP2023-06-02
05060498307345Dash 6 NRFit™GBUK GROUP LIMITEDBSP2023-06-02
10193489250428Medline Industries, Inc.MEDLINE INDUSTRIES, INC.BSP2022-08-04
10193489250510Medline Industries, Inc.MEDLINE INDUSTRIES, INC.BSP2022-08-04
10193489778083Medline Industries, Inc.MEDLINE INDUSTRIES, INC.BSP2022-08-04
10193489902822Medline Industries, Inc.MEDLINE INDUSTRIES, INC.BSP2022-08-04