FDA.reportPublic FDA data

TRAPLINER

Primary DI
30841156100562
Brand
TRAPLINER
Company
TELEFLEX INCORPORATED
Model
IPN913564
Catalog number
5568
Device description
TrapLiner 8F
Published
2018-10-01
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
DQYCatheter, percutaneous

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DQYCatheter, PercutaneousCardiovascular2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
30841156100562PackageGS11In Commercial Distribution
10841156100568PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
3084115610056230841156100562
1084115610056810841156100568

GMDN Terms#

Term, Definition table
TermDefinition
Vascular guide-catheter, single-useA flexible tube intended to be used for the percutaneous transluminal passage and placement of a diagnostic/interventional catheter, lead (e.g., pacing lead, balloon dilatation catheter), or guidewire through its lumen(s), within the vascular system. It may be rigid or flexible, non-steerable or steerable, single or multiple lumen(s), and the distal section can have a variety of preformed shapes (e.g., straight, hockey stick). It is not intended solely for infusion, is not intended to access superselective small vessels, and does not include a transseptal needle. It may include a disposable percutaneous introduction set or shaft visualization electrodes. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Catheter Gauge8French

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
false
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
04544050121057CELLO II Balloon Guide Catheter, 8F 90cmFUJI SYSTEMS CORPORATIONDQY2026-05-25
00763000821296Attain Select™ II + SureValve™MEDTRONIC, INC.DQY2026-05-22
00763000821302Attain Select™ II + SureValve™MEDTRONIC, INC.DQY2026-05-22
00763000821319Attain Select™ II + SureValve™MEDTRONIC, INC.DQY2026-05-22
00763000821326Attain Select™ II + SureValve™MEDTRONIC, INC.DQY2026-05-22
00763000821333Attain Select™ II + SureValve™MEDTRONIC, INC.DQY2026-05-22
00763000821340Attain Select™ II + SureValve™MEDTRONIC, INC.DQY2026-05-22
00763000821357Attain Select™ II + SureValve™MEDTRONIC, INC.DQY2026-05-22
00763000821364Attain Select™ II + SureValve™MEDTRONIC, INC.DQY2026-05-22
00763000821371Attain Command™ + SureValve™MEDTRONIC, INC.DQY2026-05-22
00763000821388Attain Command™ + SureValve™MEDTRONIC, INC.DQY2026-05-22
00763000821395Attain Command™ + SureValve™MEDTRONIC, INC.DQY2026-05-22
00763000821425Attain Command™ + SureValve™MEDTRONIC, INC.DQY2026-05-22
00763000821432Attain Command™ + SureValve™MEDTRONIC, INC.DQY2026-05-22
00763000821449Attain Command™ + SureValve™MEDTRONIC, INC.DQY2026-05-22
00763000821456Attain Command™ + SureValve™MEDTRONIC, INC.DQY2026-05-22
00763000821463Attain Command™ + SureValve™MEDTRONIC, INC.DQY2026-05-22
00763000821470Attain Command™ + SureValve™MEDTRONIC, INC.DQY2026-05-22
00763000821487Attain Command™ + SureValve™MEDTRONIC, INC.DQY2026-05-22
00763000821500Attain Command™ + SureValve™MEDTRONIC, INC.DQY2026-05-22
30841156103983SUPERCROSSTELEFLEX INCORPORATEDDQY2026-03-23
20841156103993SUPERCROSSTELEFLEX INCORPORATEDDQY2026-03-23
20841156104006SUPERCROSSTELEFLEX INCORPORATEDDQY2026-03-23
20841156104013SUPERCROSSTELEFLEX INCORPORATEDDQY2026-03-23
20841156104020SUPERCROSSTELEFLEX INCORPORATEDDQY2026-03-23
20841156104037SUPERCROSSTELEFLEX INCORPORATEDDQY2026-03-23
20841156104044SUPERCROSSTELEFLEX INCORPORATEDDQY2026-03-23
30841156104058SUPERCROSSTELEFLEX INCORPORATEDDQY2026-03-23
20801902195429ARROWTELEFLEX INCORPORATEDDQY2026-03-17
00857545008394ZebraQ'APEL MEDICAL LLCDQY2026-03-05