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
10887709194585BivonaFU26EN60NGA202S2026-06-03
10887709194615BivonaFT26EN50NGA210N2026-06-03
10887709194790BivonaFT26FN35NGE013N2026-06-03
10887709194806BivonaFT26FN35NGF014N2026-06-03
10887709194813BivonaHU26FS50NGF016N2026-06-03
10887709194820BivonaFT26FN45NSA017N2026-06-03
10887709194837BivonaFT26FN30NSF018N2026-06-03
10887709194844BivonaFT26FN35NGE020N2026-06-03
10887709194851BivonaFT26FN30NSE021N2026-06-03
10887709194868BivonaSU26FN50NGF022N2026-06-03
10887709194875BivonaFT26FN35NSF023N2026-06-03
10887709194882BivonaHU26FS45NSB015N2026-06-03
00887709170995ICU Medical, Inc.BAGH012026-06-02
10887709194660BivonaFP26FN45NGF003N2026-06-02
10887709194677BivonaST26EN60NTB206N2026-06-02
10887709194684BivonaST26EN60NTB207N2026-06-02
10887709194691BivonaST26EN55NTB208N2026-06-02
10887709194707BivonaST26EN55NTB209N2026-06-02
10887709194714BivonaFP26FN40NSA005N2026-06-02
10887709194721BivonaFU26FN35NSA006N2026-06-02

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