FDA.reportPublic FDA data

ARROW

Primary DI
20801902167921
Brand
ARROW
Company
TELEFLEX INCORPORATED
Model
IPN917009
Catalog number
CA-04800
Device description
One-Lumen CVC
Published
2022-02-16
Public version status
New
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
20801902167921PackageGS110In Commercial Distribution
10801902167924PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2080190216792120801902167921
1080190216792410801902167924

GMDN Terms#

Term, Definition table
TermDefinition
Central venous catheterization kit, short-termA collection of devices and materials intended for the short-term (<= 30 days) introduction of a central venous catheter (CVC) for various infusion/aspiration procedures (i.e., non-dedicated). Often referred to as tray, it includes a nonimplantable central venous catheter with devices dedicated to catheter introduction/function (e.g., introducer, guidewire), and non-dedicated supportive devices (e.g., drape, dressings, scalpel). This is a single-use device.

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
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
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