Portex

Primary DI
15019517074109
Brand
Portex
Company
ICU MEDICAL, INC.
Model
24-2018-64
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
35019517074103PackageGS110In Commercial Distribution
75019517074101PackageGS130In Commercial Distribution
15019517074109PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
3501951707410335019517074103
7501951707410175019517074101
1501951707410915019517074109

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
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
10887709197265BivonaZU26FN35NGE229N2026-07-09
10887709197289BivonaFT26FN70NSZ232N2026-07-09
10887709197838BivonaFT26GN55NGF037N2026-07-09
10887709197845BivonaST26GN55NGF038N2026-07-09
10887709197852BivonaFT26GN35NSF039N2026-07-09
10887709197869BivonaFT26GN35NSF043N2026-07-09
10887709197876BivonaFT26GN40NSF042N2026-07-09
10887709197883BivonaFU26GN35NGE044N2026-07-09
10887709197890BivonaFU26GN30NGE045N2026-07-09
10887709197906BivonaFP26GN25NGE046N2026-07-09
10887709197135BivonaXT26FS60NGC231N2026-07-08
10887709197142BivonaFT26FN35NGC234N2026-07-08
10887709197203BivonaFT26FN55NGC237N2026-07-08
10887709197210BivonaFT26FN35NSF236N2026-07-08
10887709197227BivonaFT26FN40NGE238N2026-07-08
10887709197234BivonaFT26FN40NGE239N2026-07-08
10887709197241BivonaFT26FN60NGC240N2026-07-08
10887709197722BivonaHT26GS70NSC029N2026-07-08
10887709197739BivonaFT26GN35NSE030N2026-07-08
10887709197746BivonaFT26GN30NSF031N2026-07-08

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
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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
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20809160323509HalyardAVID MEDICAL, INC.MIA2020-12-11
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20809160323639HalyardAVID MEDICAL, INC.MIA2020-12-11
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20809160323691HalyardAVID MEDICAL, INC.MIA2020-12-11
20809160323707HalyardAVID MEDICAL, INC.MIA2020-12-11
15019517063479PortexICU MEDICAL, INC.MIA2020-03-09
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15019517063530PortexICU MEDICAL, INC.MIA2020-03-09
15019517070576PortexICU MEDICAL, INC.MIA2020-03-09
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