FDA.reportPublic FDA data

ARROW

Primary DI
20801902004004
Brand
ARROW
Company
TELEFLEX INCORPORATED
Model
IPN033571
Catalog number
PW-18130-P
Device description
Spring-Wire Guide .018" (0.46 mm) diameter x 51-3/16" (130 cm) Marked Wire
Published
2019-01-07
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
LJSCatheter, intravascular, therapeutic, long-term greater than 30 days

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LJSCatheter, Intravascular, Therapeutic, Long-Term Greater Than 30 DaysGeneral Hospital2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20801902004004PackageGS15Not in Commercial Distribution
10801902004007PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2080190200400420801902004004
1080190200400710801902004007

GMDN Terms#

Term, Definition table
TermDefinition
Peripheral vascular guidewire, manualA long, thin, sterile wire intended to be percutaneously placed into the peripheral vasculature (not heart or central nervous system) to function as a guide for the introduction of devices (e.g., catheters). It is made of metal (e.g., stainless steel, Nitinol), with or without coating, and is available in a variety of distal tip designs. It is intended to be used for percutaneous angiography, angioplasty, rotational atherectomy and thrombectomy, drainage, and other diagnostic and interventional procedures. It may include devices used to facilitate manipulation (e.g., torque device). This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length130Centimeter

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(919)544-8000CS@TELEFLEX.COM

Regulatory Flags#

DUNS number
002348191
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
false
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
20801902219385ARROWEDC-00622EDC-006222026-03-24
30801902219405ARROWEDC-00820EDC-008202026-03-24
20801902219415ARROWEDC-00822EDC-008222026-03-24
20801902219460ARROWEDC-00818-MEDC-00818-M2026-03-24
20801902219484ARROWEDC-00622-HCEDC-00622-HC2026-03-24
20801902219514ARROWEDC-00822-HCEDC-00822-HC2026-03-24
20801902193418ARROWIPN920120AW-04432-N2026-03-23
30841156103983SUPERCROSS530253022026-03-23
20841156103993SUPERCROSS530353032026-03-23
20841156104006SUPERCROSS530453042026-03-23
20841156104013SUPERCROSS530553052026-03-23
20841156104020SUPERCROSS530653062026-03-23
20841156104037SUPERCROSS530753072026-03-23
20841156104044SUPERCROSS530853082026-03-23
30841156104058SUPERCROSS530953092026-03-23
24026704941494PILLINGP12797P127972026-03-23
24026704941500PILLINGP12805P128052026-03-23
24026704941555PILLINGP13063P130632026-03-23
24026704941562PILLINGP13065P130652026-03-23
24026704941579PILLINGP13081P130812026-03-23

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10801741239356PowerPICC Sherlock 3CGBard Access Systems, Inc.LJS2026-03-11
10801741239363PowerPICC ProvenaBard Access Systems, Inc.LJS2026-03-11
10801741239370PowerPICC ProvenaBard Access Systems, Inc.LJS2026-03-11
50884908135782PRO-LINE® CT PRESSURE INJECTABLE CVC (ISOPLAST)Medical Components, Inc.LJS2026-02-17
50884908143855PRO-LINE® CT PRESSURE INJECTABLE CVC (ISOPLAST)Medical Components, Inc.LJS2026-02-17
50884908143862PRO-LINE® CT PRESSURE INJECTABLE CVC (ISOPLAST)Medical Components, Inc.LJS2026-02-17
50884908143879PRO-PICC® CT PRESSURE INJECTABLE CVC (ISOPLAST)Medical Components, Inc.LJS2026-02-17
50884908152703PRO-PICC® CTMedical Components, Inc.LJS2026-02-17
50884908154714PRO-PICC® CTMedical Components, Inc.LJS2026-02-17
50884908154721PRO-PICC® CTMedical Components, Inc.LJS2026-02-17
50884908160234PRO-PICC® CTMedical Components, Inc.LJS2026-02-17
50884908160258PRO-PICC® CTMedical Components, Inc.LJS2026-02-17
50884908174361PRO-PICC® CTMedical Components, Inc.LJS2026-02-17
50884908184094VASCU-PICC® AND MIDLINE CATHETERSMedical Components, Inc.LJS2026-02-13
50884908184100VASCU-PICC® AND MIDLINE CATHETERSMedical Components, Inc.LJS2026-02-13
50884908184117VASCU-PICC® AND MIDLINE CATHETERSMedical Components, Inc.LJS2026-02-13
50884908184124VASCU-PICC® AND MIDLINE CATHETERSMedical Components, Inc.LJS2026-02-13
50884908184278VASCU-PICC® AND MIDLINE CATHETERSMedical Components, Inc.LJS2026-02-13
50884908184285VASCU-PICC® AND MIDLINE CATHETERSMedical Components, Inc.LJS2026-02-13
50884908184292VASCU-PICC® AND MIDLINE CATHETERSMedical Components, Inc.LJS2026-02-13
50884908184308VASCU-PICC® AND MIDLINE CATHETERSMedical Components, Inc.LJS2026-02-13
50884908184315VASCU-PICC® AND MIDLINE CATHETERSMedical Components, Inc.LJS2026-02-13
50884908184322VASCU-PICC® AND MIDLINE CATHETERSMedical Components, Inc.LJS2026-02-13
10801741238830PowerPICC Provena SOLOBard Access Systems, Inc.LJS2026-02-11
50884908062415VASCU-PICC® (TAPERLESS)Medical Components, Inc.LJS2026-01-31
50884908062446VASCU-PICC® (TAPERLESS)Medical Components, Inc.LJS2026-01-31
50884908062477VASCU-PICC® (TAPERLESS)Medical Components, Inc.LJS2026-01-31
50884908062729VASCU-PICC® (TAPERLESS)Medical Components, Inc.LJS2026-01-31
50884908062804MEDCOMP PRO-PICC WITH VALVE TECHNOLOGYMedical Components, Inc.LJS2026-01-31
50884908062811MEDCOMP PRO-PICC WITH VALVE TECHNOLOGYMedical Components, Inc.LJS2026-01-31