FDA.reportPublic FDA data

ARROW

Primary DI
10801902193114
Brand
ARROW
Company
TELEFLEX INCORPORATED
Model
IPN920089
Catalog number
CDC-29803-XCN1A
Published
2026-07-30
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
DYBIntroducer, catheter

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DYBIntroducer, CatheterCardiovascular2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20801902193111PackageGS15In Commercial Distribution
10801902193114PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2080190219311120801902193111
1080190219311410801902193114

GMDN Terms#

Term, Definition table
TermDefinition
Vascular catheter introduction set, nonimplantableA collection of nonimplantable, invasive devices intended to provide percutaneous vascular access to enable introduction of a catheter (not included) into the vascular system. It includes a non-steerable introducer sheath with an inner obturator/dilator and/or a vascular catheter introduction needle (e.g., arterial needle), and typically an additional access device(s) [e.g., guidewire, syringe, additional dilators] which may include a haemostatic valve to control blood loss, usually for arterial access; some sets include in addition noninvasive supportive devices (e.g., drapes, dressings). This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature00

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
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
10801902210897ARROWIPN925094ASK-21142-HF52026-08-04
10801902210903ARROWIPN925095ASK-21142-SG22026-08-04
10801902210934ARROWIPN925098ASK-21242-SL12026-08-04
10801902227116ARROWIPNB00557ASK-29903-CFV2026-08-31
10801902227208ARROWIPNB00556ASK-29803-CFV2026-08-31
30801902124921ARROWIPN037387ASK-04100-AMC-S12026-10-13
10801902226188ARROWIPNB00349SI-111422026-09-28
10801902226195ARROWIPNB00348SI-112422026-09-28
10801902228700ARROWCDC-09903-1ACDC-09903-1A2026-09-22
10801902227109ARROWIPNB00297ASK-09601-CF2026-09-03
10801902227246ARROWIPNB00152ASK-29903-BSWH2026-08-27
10801902226416ARROWIPNB00521ASK-21242-UR32026-08-03
10801902193121ARROWIPN920090CDC-29803-XN1A2026-07-30
10801902193190ARROWIPN920097CDC-29903-XCN1A2026-07-30
10801902193206ARROWIPN920098CDC-29903-XN1A2026-07-30
10801902196184ARROWIPN920629EI-040602026-07-30
10801902196498ARROWIPN920660CDC-21142-XCN1A2026-07-30
10801902196511ARROWIPN920662CDC-21242-XCN1A2026-07-30
10801902196528ARROWIPN920663CDC-21242-XN1A2026-07-30
10801902200768ARROWIPN921145CL-078352026-07-30

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00198715836998EMPOWER™ INTRODUCER SHEATH WITH HYDROPHILIC COATINGFREUDENBERG MEDICAL, LLCDYB2026-01-29
00389701011912GLIDESHEATH SLENDER TIBIAL PEDAL KITTERUMO MEDICAL CORPORATIONDYB2018-08-31
00389701011950GLIDESHEATH SLENDERTERUMO MEDICAL CORPORATIONDYB2018-05-23
00389701011967GLIDESHEATH SLENDERTERUMO MEDICAL CORPORATIONDYB2018-05-23
00389701011974GLIDESHEATH SLENDERTERUMO MEDICAL CORPORATIONDYB2018-05-23
00389701011981GLIDESHEATH SLENDERTERUMO MEDICAL CORPORATIONDYB2018-05-23
00389701009261PINNACLETERUMO MEDICAL CORPORATIONDYB2018-03-21
00382903840120BD Introsyte AutoguardBECTON, DICKINSON AND COMPANYDYB2016-10-20
00382903840083BD Introsyte-N Autoguard, BD InstaflashBECTON, DICKINSON AND COMPANYDYB2016-10-20
00382903840106BD Introsyte AutoguardBECTON, DICKINSON AND COMPANYDYB2016-10-20
00382903840113BD Introsyte AutoguardBECTON, DICKINSON AND COMPANYDYB2016-10-20
00389701006161DESTINATIONTERUMO MEDICAL CORPORATIONDYB2016-09-24
00389701006178DESTINATIONTERUMO MEDICAL CORPORATIONDYB2016-09-24
00389701006185DESTINATIONTERUMO MEDICAL CORPORATIONDYB2016-09-24
00389701006192DESTINATIONTERUMO MEDICAL CORPORATIONDYB2016-09-24
00389701006208DESTINATIONTERUMO MEDICAL CORPORATIONDYB2016-09-24
00389701006215DESTINATIONTERUMO MEDICAL CORPORATIONDYB2016-09-24
00389701006222DESTINATIONTERUMO MEDICAL CORPORATIONDYB2016-09-24
00389701006239DESTINATIONTERUMO MEDICAL CORPORATIONDYB2016-09-24
00389701006246DESTINATIONTERUMO MEDICAL CORPORATIONDYB2016-09-24
00389701006253DESTINATIONTERUMO MEDICAL CORPORATIONDYB2016-09-24
00389701006260DESTINATIONTERUMO MEDICAL CORPORATIONDYB2016-09-24
00389701006277DESTINATIONTERUMO MEDICAL CORPORATIONDYB2016-09-24
00389701006796DESTINATIONTERUMO MEDICAL CORPORATIONDYB2016-09-24
00389701006802DESTINATIONTERUMO MEDICAL CORPORATIONDYB2016-09-24
00389701006970DESTINATIONTERUMO MEDICAL CORPORATIONDYB2016-09-24
00389701006987DESTINATIONTERUMO MEDICAL CORPORATIONDYB2016-09-24
00389701006994DESTINATIONTERUMO MEDICAL CORPORATIONDYB2016-09-24
00389701007007DESTINATIONTERUMO MEDICAL CORPORATIONDYB2016-09-24
00389701007168DESTINATIONTERUMO MEDICAL CORPORATIONDYB2016-09-24