FDA.reportPublic FDA data

PremierPro™

Primary DI
00811220033941
Brand
PremierPro™
Company
PRESTIGE AMERITECH, LTD.
Model
31C14125
Catalog number
31C14125
Device description
PremierPro™ by MedSource ClearSafe Comfort® Safety IV Catheter, 14G x 1.25in, 1 each
Published
2022-07-07
Public version status
Update
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
FOZCatheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FOZCatheter, Intravascular, Therapeutic, Short-Term Less Than 30 DaysGeneral Hospital2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K150611000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K150611000MedSource ClearSafe Safety IV CatheterMedsource International2015-07-15FOZ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00811220033989PackageGS150In Commercial Distribution
00811220033996PackageGS14In Commercial Distribution
00811220033941PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00811220033989008112200339898112200339890811220033989
00811220033996008112200339968112200339960811220033996
00811220033941008112200339418112200339410811220033941

GMDN Terms#

Term, Definition table
TermDefinition
Intravenous line recessed-needle connectorA sterile device designed to allow access to either the Y-site of an intravenous (IV) line or an injection adaptor on the infusion catheter. Typically, a needle located inside a plastic housing can be inserted into a standard septum and a Luer fitting located at the opposite end allows the connection of a syringe or infusion set. A manual or automated mechanism moves the housing to protect the operator from the needle once the infusion is finished. The device is intended to eliminate an exposed needle after administration of medications. This is a single-use device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
1-855-531-7699udi@s2s-global.com

Regulatory Flags#

DUNS number
199692794
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
00811220035433PremierProD5061D50612024-03-08
00811220035440PremierProD5062D50622024-03-08
00811220035457PremierProD5063D50632024-03-08
00811220035464PremierProD5064D50642024-03-08
00811220035471PremierProD5065D50652024-03-08
00852212003269ProKidsFM85030-CCM12016-09-26
00852212003344ProGearFM85011-CCM12016-09-26
00852212003214ProKidsFM850302016-09-26
00852212003801ProGear7410E32026-04-21
00852212003788PrestigePro24512026-03-27
00852212003795PrestigePro24532026-03-27
00818566016454PremierPro24512016-07-15
00818566019783PremierPro24532020-04-28
20818566017479PremierPro531153112020-07-15
20818566017486PremierPro531253122020-07-15
00811220030001PremierPro6604PP6604PP2020-09-08
00811220030018PremierPro6605PP6605PP2020-09-08
00811220030032PremierPro24922020-04-28
00811220030049PremierPro881788172020-08-29
00811220030056PremierPro881888182020-08-29

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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10801902222975ARROWTELEFLEX INCORPORATEDFOZ2026-08-19
10801902226454ARROWTELEFLEX INCORPORATEDFOZ2026-08-10
10801902219210ARROWTELEFLEX INCORPORATEDFOZ2026-08-03
10801902130546ARROWTELEFLEX INCORPORATEDFOZ2026-08-01
10801902218084ARROWTELEFLEX INCORPORATEDFOZ2026-08-01
10801902218404ARROWTELEFLEX INCORPORATEDFOZ2026-08-01
10801902224436ARROWTELEFLEX INCORPORATEDFOZ2026-08-01
00382903935314NexivaBECTON, DICKINSON AND COMPANYFOZ2026-07-30
00382903935321NexivaBECTON, DICKINSON AND COMPANYFOZ2026-07-30
00382903935338NexivaBECTON, DICKINSON AND COMPANYFOZ2026-07-30
00382903935345NexivaBECTON, DICKINSON AND COMPANYFOZ2026-07-30
00382903935352NexivaBECTON, DICKINSON AND COMPANYFOZ2026-07-30
00382903935369NexivaBECTON, DICKINSON AND COMPANYFOZ2026-07-30
00382903935376NexivaBECTON, DICKINSON AND COMPANYFOZ2026-07-30
00382903935383NexivaBECTON, DICKINSON AND COMPANYFOZ2026-07-30
10801902167344ARROWTELEFLEX INCORPORATEDFOZ2026-07-30
10801902129700ARROWTELEFLEX INCORPORATEDFOZ2026-07-28
10801902167351ARROWTELEFLEX INCORPORATEDFOZ2026-07-28
10801902167894ARROWTELEFLEX INCORPORATEDFOZ2026-07-28
10801902226379ARROWTELEFLEX INCORPORATEDFOZ2026-07-14
10801902226386ARROWTELEFLEX INCORPORATEDFOZ2026-07-14
10801902226140ARROWTELEFLEX INCORPORATEDFOZ2026-06-12
10801902226157ARROWTELEFLEX INCORPORATEDFOZ2026-06-12
10801902226164ARROWTELEFLEX INCORPORATEDFOZ2026-06-12
00850073657003Ruby Intravascular CatheterVenocare, Inc.FOZ2026-04-08
10801902219449ARROWTELEFLEX INCORPORATEDFOZ2026-03-06
10192253040241ArgyleCardinal Health 200, LLCFOZ2025-01-08