Portex

Primary DI
15019517070699
Brand
Portex
Company
ICU MEDICAL, INC.
Model
24-2011-64
Published
2020-03-09
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
MIANEEDLE, SPINAL, SHORT TERM

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MIANeedle, Spinal, Short TermAnesthesiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K172800000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K172800000Portex® Lancet Point Spinal Needles with NRFit™ connectors, Portex® Pencil Point Spinal Needles with NRFit™ connectorsSmiths Medical Asd, Inc.2018-06-14MIA

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
35019517070693PackageGS120In Commercial Distribution
55019517070697PackageGS110In Commercial Distribution
15019517070699PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
3501951707069335019517070693
5501951707069755019517070697
1501951707069915019517070699

GMDN Terms#

Term, Definition table
TermDefinition
Spinal needle, single-useA sharp bevel-edged, hollow tubular instrument designed for short-term use to withdraw a sample of cerebrospinal fluid (CSF), assist introduction of a spinal guidewire or catheter (e.g., lumboperitoneal shunt, intrathecal catheter), and/or deliver contrast media and/or anaesthetic or analgesic agents intrathecally (subarachnoid) or into a vertebral disc, either directly or using the needle-through-needle technique. It is typically fenestrated, spring-tipped, and made of metal and/or plastic materials; some types may be semi-rigid and include a stylet for support during handling. This is a single-use device.

Regulatory Flags#

DUNS number
118380146
Device count
1
Kit
true
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
10887709199870BivonaFU26GN40NSC236N2026-07-30
10887709199887BivonaFU26GN30NSC235N2026-07-30
10887709199894BivonaFU26GN30NSF235N2026-07-30
10887709199689BivonaFU26GN60NGF229N2026-07-29
10887709199696BivonaFT26GN45NSF228N2026-07-29
10887709199702BivonaST26GN50NGF231N2026-07-29
10887709199719BivonaFT26GN40NGF230N2026-07-29
10887709199726BivonaFT26GN65NSC225N2026-07-29
10887709199733BivonaSU26GN45NSC223N2026-07-29
10887709199740BivonaSU26GN40NSC222N2026-07-29
10887709199757BivonaFT26GN60NSF232N2026-07-29
10887709199658BivonaFT26GN25NSA221N2026-07-28
10887709199665BivonaST26GN55NSB224N2026-07-28
10887709198804BivonaFT26GN45NSF145N2026-07-27
10887709199252BivonaFU26GN50NSF160N2026-07-27
10887709199269BivonaFT26GN55NGF161N2026-07-27
10887709199276BivonaFP26GN40NSF163N2026-07-27
10887709199283BivonaFU26GN45NSA164N2026-07-27
10887709199290BivonaFT26GN40NGE162N2026-07-27
10887709199306BivonaFT26FN80NSC026S2026-07-27

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00818788023698Epimed International, Inc.EPIMED INTERNATIONAL, INCMIA2022-05-05
10818788023695Epimed International, Inc.EPIMED INTERNATIONAL, INCMIA2022-05-05
10809160323502HalyardAVID MEDICAL, INC.MIA2020-12-11
10809160323618HalyardAVID MEDICAL, INC.MIA2020-12-11
10809160323625HalyardAVID MEDICAL, INC.MIA2020-12-11
10809160323632HalyardAVID MEDICAL, INC.MIA2020-12-11
10809160323649HalyardAVID MEDICAL, INC.MIA2020-12-11
10809160323656HalyardAVID MEDICAL, INC.MIA2020-12-11
10809160323663HalyardAVID MEDICAL, INC.MIA2020-12-11
10809160323670HalyardAVID MEDICAL, INC.MIA2020-12-11
10809160323687HalyardAVID MEDICAL, INC.MIA2020-12-11
10809160323694HalyardAVID MEDICAL, INC.MIA2020-12-11
10809160323700HalyardAVID MEDICAL, INC.MIA2020-12-11
20809160323509HalyardAVID MEDICAL, INC.MIA2020-12-11
20809160323615HalyardAVID MEDICAL, INC.MIA2020-12-11
20809160323622HalyardAVID MEDICAL, INC.MIA2020-12-11
20809160323639HalyardAVID MEDICAL, INC.MIA2020-12-11
20809160323646HalyardAVID MEDICAL, INC.MIA2020-12-11
20809160323653HalyardAVID MEDICAL, INC.MIA2020-12-11
20809160323660HalyardAVID MEDICAL, INC.MIA2020-12-11
20809160323677HalyardAVID MEDICAL, INC.MIA2020-12-11
20809160323684HalyardAVID MEDICAL, INC.MIA2020-12-11
20809160323691HalyardAVID MEDICAL, INC.MIA2020-12-11
20809160323707HalyardAVID MEDICAL, INC.MIA2020-12-11
15019517063479PortexICU MEDICAL, INC.MIA2020-03-09
15019517063523PortexICU MEDICAL, INC.MIA2020-03-09
15019517063530PortexICU MEDICAL, INC.MIA2020-03-09
15019517070576PortexICU MEDICAL, INC.MIA2020-03-09
15019517070606PortexICU MEDICAL, INC.MIA2020-03-09
15019517070637PortexICU MEDICAL, INC.MIA2020-03-09