FDA.reportPublic FDA data

PME014B

Primary DI
00850005864547
Brand
PME014B
Company
PATHEN MEDICAL LLC
Model
PME014B
Device description
"14"" Microbore extenstion set with bonded needle-free connector"
Published
2019-07-25
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
FPASet, Administration, Intravascular

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FPASet, Administration, IntravascularGeneral Hospital2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10850005864544PackageGS150In Commercial Distribution
00850005864547PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1085000586454410850005864544
00850005864547008500058645478500058645470850005864547

GMDN Terms#

Term, Definition table
TermDefinition
Intravenous administration tubing extension setA collection of tubing and connectors intended to establish an extension of tubing where the standard length of the tubing in an intravenous (IV) administration set is insufficient. This is a single-use device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
8773185421questions@pathen.com

Regulatory Flags#

DUNS number
042928915
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850005864233PR-84214PR-842142019-04-24
00850005864240PR-84216PR-842162019-04-24
00850005864257PR-84218PR-842182019-04-24
00850005864264PR-84220PR-842202019-04-24
00850005864271PR-842202PR-8422022019-04-24
00850005864288PR-84222PR-842222019-04-24
00850005864295PR-84224PR-842242019-04-24
00850005864301PS-84314PS-843142019-04-24
00850005864318PS-84316PS-843162019-04-24
00850005864325PS-84318PS-843182019-04-24
00850005864332PS-843182PS-8431822019-04-24
00850005864349PS-843202PS-8432022019-04-24
00850005864356PS-843203PS-8432032019-04-24
00850005864363PS-84322PS-843222019-04-24
00850005864370PS-84324PS-843242019-04-24
00850005864608BMS-2135.17SBMS-2135.17S2019-09-09
00850005864646PS-84320PS-843202019-11-08
20850005864640PS-84320PS-843202019-11-08
00850005864615PS-843242PS-8432422019-11-05
00850005864622PS-84326PS-843262019-11-05

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00827989008243MedSafetyHealth Care Logistics, Inc.FPA2026-07-10
05051684018473LifeportAngiodynamics, Inc.FPA2026-06-23
05051684018480LifeportAngiodynamics, Inc.FPA2026-06-23
05051684018497LifeportAngiodynamics, Inc.FPA2026-06-23
05051684018503LifeportAngiodynamics, Inc.FPA2026-06-23
05051684018510LifeportAngiodynamics, Inc.FPA2026-06-23
05051684018527LifeportAngiodynamics, Inc.FPA2026-06-23
05051684018534LifeportAngiodynamics, Inc.FPA2026-06-23
05051684018541LifeportAngiodynamics, Inc.FPA2026-06-23
05051684018558LifeportAngiodynamics, Inc.FPA2026-06-23
05051684018565LifeguardAngiodynamics, Inc.FPA2026-06-23
05051684018572LifeguardAngiodynamics, Inc.FPA2026-06-23
05051684018589LifeguardAngiodynamics, Inc.FPA2026-06-23
05051684018596LifeguardAngiodynamics, Inc.FPA2026-06-23
05051684018602LifeguardAngiodynamics, Inc.FPA2026-06-23
05051684018619LifeguardAngiodynamics, Inc.FPA2026-06-23
05051684018626LifeguardAngiodynamics, Inc.FPA2026-06-23
05051684018633LifeguardAngiodynamics, Inc.FPA2026-06-23
05051684018640LifeguardAngiodynamics, Inc.FPA2026-06-23
00811505030573IvenixFresenius Kabi AGFPA2026-06-02
00382905168031BD Intelliport SystemBECTON, DICKINSON AND COMPANYFPA2024-06-07
00382905168000BD Intelliport SystemBECTON, DICKINSON AND COMPANYFPA2024-06-07
04038917423410Safety-Multifly® 23G w.holderSarstedt Aktiengesellschaft & Co.KGFPA2024-02-20
08436020769177DOSI-FLOWLEVENTON SAUFPA2023-09-08
00085412676630DUO-VENTBAXTER HEALTHCARE CORPORATIONFPA2023-07-11
00634624911109Precision Delivery Bifurcated IV Extension SetQUEST MEDICAL INCFPA2022-12-19
00634624911048High-Flow Extension SetQUEST MEDICAL INCFPA2022-12-12
00634624101159Q2 IV Administration SetQUEST MEDICAL INCFPA2022-12-06
00634624101258Q2 IV Administration SetQUEST MEDICAL INCFPA2022-12-06
00634624101302Q2 IV Administration SetQUEST MEDICAL INCFPA2022-12-06