Portex

Primary DI
15019517070682
Brand
Portex
Company
ICU MEDICAL, INC.
Model
24-2010-64
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
35019517070686PackageGS120In Commercial Distribution
55019517070680PackageGS110In Commercial Distribution
15019517070682PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
3501951707068635019517070686
5501951707068055019517070680
1501951707068215019517070682

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
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
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
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10809160323632HalyardAVID MEDICAL, INC.MIA2020-12-11
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10809160323656HalyardAVID 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
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