FDA.reportPublic FDA data

PremierPro™

Primary DI
00811220034535
Brand
PremierPro™
Company
SVS LLC
Model
31T20116
Catalog number
31T20116
Device description
PremierPro™ by MedSource TrueSafe Comfort® Safety IV Catheter, 20G x 1.16in, 1 each
Published
2022-12-19
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00811220034535PackageGS150In Commercial Distribution
00811220034542PackageGS14In Commercial Distribution
00811220034528PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00811220034535008112200345358112200345350811220034535
00811220034542008112200345428112200345420811220034542
00811220034528008112200345288112200345280811220034528

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
831375089
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
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
00811220035495PremierPro882088202024-10-28
00811220035518PremierPro882188212024-10-28
10811220035430PremierProD5061D50612024-03-08
10811220035447PremierProD5062D50622024-03-08
10811220035454PremierProD5063D50632024-03-08
10811220035461PremierProD5064D50642024-03-08
10811220035478PremierProD5065D50652024-03-08
00811220035143PremierProFL1003DFL1003D2024-02-14
00811220035174PremierProFL1005DFL1005D2024-02-14
00811220035099PremierProFL1010DFL1010D2024-02-14
00811220035112PremierProFL1010SFFL1010SF2024-02-14
00811220034412PremierPro™31T1417531T141752022-12-19
00811220034443PremierPro™31T1617731T161772022-12-19
00811220034474PremierPro™31T1811631T181162022-12-19
00811220034504PremierPro™31T1818831T181882022-12-19
00811220034566PremierPro™31T2010031T201002022-12-19
00811220034597PremierPro™31T2018831T201882022-12-19
00811220034627PremierPro™31T2210031T221002022-12-19
00811220034658PremierPro™31T2407531T240752022-12-19
00811220034689PremierPro™31TB1617731TB161772022-12-19

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10192253040241ArgyleCardinal Health 200, LLCFOZ2025-01-08
10192253040258ArgyleCardinal Health 200, LLCFOZ2025-01-08
10192253040265ArgyleCardinal Health 200, LLCFOZ2025-01-08
10801902102901ARROWTELEFLEX INCORPORATEDFOZ2019-12-10
10801902130331ARROWTELEFLEX INCORPORATEDFOZ2017-11-30
10801902130355ARROWTELEFLEX INCORPORATEDFOZ2017-11-30
10801902130379ARROWTELEFLEX INCORPORATEDFOZ2017-11-30
10801902133004ARROWTELEFLEX INCORPORATEDFOZ2017-04-12
10801902133028ARROWTELEFLEX INCORPORATEDFOZ2017-04-12
10801902133042ARROWTELEFLEX INCORPORATEDFOZ2017-04-12
10801902133066ARROWTELEFLEX INCORPORATEDFOZ2017-04-12
10801902133080ARROWTELEFLEX INCORPORATEDFOZ2017-04-12
10801902133233ARROWTELEFLEX INCORPORATEDFOZ2017-03-08
10801902133127ARROWTELEFLEX INCORPORATEDFOZ2017-03-07
10801902132816ARROWTELEFLEX INCORPORATEDFOZ2017-03-02
10801902132823ARROWTELEFLEX INCORPORATEDFOZ2017-03-02
10801902133097ARROWTELEFLEX INCORPORATEDFOZ2017-03-02
10801902133103ARROWTELEFLEX INCORPORATEDFOZ2017-03-02
10801902131529ARROWTELEFLEX INCORPORATEDFOZ2017-02-17
10801902131512ARROWTELEFLEX INCORPORATEDFOZ2017-02-15
10801902131567ARROWTELEFLEX INCORPORATEDFOZ2017-02-15
00801741074769Excalibur Introducer SystemBard Access Systems, Inc.FOZ2017-02-03
00801741074783Excalibur Introducer SystemBard Access Systems, Inc.FOZ2017-02-03
10801902131178ARROWTELEFLEX INCORPORATEDFOZ2017-01-13
10801902130898ARROWTELEFLEX INCORPORATEDFOZ2016-12-21
10801902130904ARROWTELEFLEX INCORPORATEDFOZ2016-12-21
10801902130911ARROWTELEFLEX INCORPORATEDFOZ2016-12-21
10801902130928ARROWTELEFLEX INCORPORATEDFOZ2016-12-21
10801902130935ARROWTELEFLEX INCORPORATEDFOZ2016-12-21
10801902129359ARROWTELEFLEX INCORPORATEDFOZ2016-11-11