Portex

Primary DI
55019517075036
Brand
Portex
Company
Smiths Medical ASD, Inc.
Model
24-2024-64
Published
2020-03-09
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true
OTC
false
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
35019517075032PackageGS120In Commercial Distribution
55019517075036PackageGS110In Commercial Distribution
15019517075038PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
3501951707503235019517075032
5501951707503655019517075036
1501951707503815019517075038

GMDN Terms#

Term, Definition table
TermDefinition
Spinal needle, single-useA sterile, sharp bevel-edged, hollow tubular metal instrument designed to deliver anaesthetic or analgesic agents intrathecally (in the space under the arachnoid membrane of the brain and spinal cord), withdraw a sample of cerebrospinal fluid (CSF), and/or assist introduction of an intrathecal catheter (e.g., lumboperitoneal shunt, spinal catheter). It is typically fenestrated, spring-tipped, and used for short-term administration; it is typically made of metal and plastic materials. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
082005361
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
true
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
50351688508896MedexMX207752016-10-11
50351688508933MedexMX207552016-10-11
50610674800094PortexH4003PS2015-09-01
30610674802094PortexH4021PS2015-09-01
30610674802780PortexH4022PS2015-09-01
50351688500302MedexTF562016-10-13
50351688500319MedexTF552016-12-29
50351688500487MedexSM7223SC2016-10-13
50351688500555MedexSM50142017-01-03
50351688500647MedexSM50042017-01-03
50351688500654MedexSM50032017-01-03
50351688504638MedexMX8702016-10-13
50351688505031MedexMX8012016-10-13
50351688505406MedexMX7452017-02-27
50351688505413MedexMX7432016-10-13
50351688506878MedexMX4982016-10-12
50351688506922MedexMX4922016-10-12
50351688507097MedexMX457L2016-10-12
50351688507103MedexMX4572016-10-12
50351688507189MedexMX453L2016-10-12

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
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