FDA.reportPublic FDA data

ARROW

Primary DI
10801902180275
Brand
ARROW
Company
TELEFLEX INCORPORATED
Model
IPN917221
Catalog number
AI-07122
Device description
CATH PKGD: WEDGE 4 FR 110CM
Published
2021-08-09
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
DYGCATHETER, FLOW DIRECTED

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DYGCatheter, Flow DirectedCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K892530000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K892530000CATHETERS FOR BALLOON OCCLUSION FEMORAL ANGIOGRAPHArrow Intl., Inc.1989-09-26DYG

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20801902180272PackageGS15In Commercial Distribution
10801902180275PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2080190218027220801902180272
1080190218027510801902180275

GMDN Terms#

Term, Definition table
TermDefinition
Pulmonary artery balloon catheter, non-electricalA flexible, non-electrical tube with an inflatable balloon at its distal tip designed to be introduced percutaneously into the venous system via a central vein (e.g., jugular, subclavian), and advanced from the superior vena cava to the pulmonary artery, to measure/monitor a haematological parameter(s) [e.g., pulmonary arterial pressures (e.g., wedge), stroke volume] via the pressure changes at its distal tip. Also referred to as a Swan-Ganz catheter, it is typically used in conjunction with a parent device (e.g., external blood pressure transducer) and may include devices dedicated to introduction. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Catheter Gauge4French
Length110Centimeter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Store at normal room temperature away from direct exposure to light. Prolonged exposure to fluorescent light, sunlight or heat will damage the balloon

Contacts#

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

Regulatory Flags#

DUNS number
002348191
Device count
1
Lot or batch
true
Expiration date on label
true
Contains natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10801902228205ARROWIPNB00283ASK-45703-NCC32026-09-25
10801902228212ARROWIPNB00282ASK-45802-NCC2026-09-25
10801902228700ARROWCDC-09903-1ACDC-09903-1A2026-09-22
10801902228717ARROWCDA-42703-XPCN1ACDA-42703-XPCN1A2026-09-22
04026704916955RUSCHIPN9007315640002026-08-03
10841156111519TELEFLEXIPN93068158822025-06-12
10841156111540TELEFLEXIPN93068258842025-06-12
10841156111595TELEFLEXIPN93068458882025-06-12
10841156111755TELEFLEXIPN93068358862025-06-12
14026704302182RUSCHIPN0505091807051202016-09-16
14026704302205RUSCHIPN0505111807051402016-09-16
14026704302229RUSCHIPN0505131807051602016-09-16
14026704302243RUSCHIPN0505151807051802016-09-16
14026704302267RUSCHIPN0505171807052002016-09-16
14026704302281RUSCHIPN0505191807052202016-09-16
14026704302304RUSCHIPN0505211807052402016-09-16
14026704302328RUSCHIPN0505231807052602016-09-16
14026704302342RUSCHIPN0505251807052802016-09-16
14026704302366RUSCHIPN0505271807053002016-09-16
14026704302977RUSCHIPN0505911834052002016-09-16

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00885403521174SWAN-GANZBecton, Dickinson And CompanyDYG2026-09-04
00885403521525SWAN-GANZBecton, Dickinson And CompanyDYG2026-09-04
00885403521624SWAN-GANZBecton, Dickinson And CompanyDYG2026-09-04
00885403522324Swan-GanzBecton, Dickinson And CompanyDYG2026-07-31
00885403522393Swan-GanzBecton, Dickinson And CompanyDYG2026-07-27
00885403522300Swan-GanzBecton, Dickinson And CompanyDYG2026-07-24
00885403522331Swan-GanzBecton, Dickinson And CompanyDYG2026-07-24
00885403522270Swan-GanzBecton, Dickinson And CompanyDYG2026-05-30
00885403522348SWAN-GANZ CCOMBO VBecton, Dickinson And CompanyDYG2026-05-30
00885403522386Swan-GanzBecton, Dickinson And CompanyDYG2026-05-30
00690103218282SWAN-GANZ VIPEdwards Lifesciences LLCDYG2026-03-16
00690103218602SWAN-GANZ TRUE SIZEEdwards Lifesciences LLCDYG2026-03-16
00690103218626SWAN-GANZ TRUE SIZEEdwards Lifesciences LLCDYG2026-03-16
00690103218633SWAN-GANZ TRUE SIZEEdwards Lifesciences LLCDYG2026-03-16
00690103000382SWAN-GANZ TRUE SIZEEdwards Lifesciences LLCDYG2026-03-16
50690103218287SWAN-GANZ VIPEdwards Lifesciences LLCDYG2026-03-16
50690103218638SWAN-GANZ TRUE SIZEEdwards Lifesciences LLCDYG2026-03-16
00690103217094Swan-GanzEdwards Lifesciences LLCDYG2025-07-11
00690103219371SWAN GANZEdwards Lifesciences LLCDYG2024-08-30
00690103219289SWAN GANZEdwards Lifesciences LLCDYG2024-08-30
00690103219388SWAN-GANZEdwards Lifesciences LLCDYG2024-08-05
10801902206333ARROWTELEFLEX INCORPORATEDDYG2022-10-20
10801902206432ARROWTELEFLEX INCORPORATEDDYG2022-10-20
10801902206456ARROWTELEFLEX INCORPORATEDDYG2022-10-20
20801902206330ARROWTELEFLEX INCORPORATEDDYG2022-10-20
20801902206439ARROWTELEFLEX INCORPORATEDDYG2022-10-20
20801902206453ARROWTELEFLEX INCORPORATEDDYG2022-10-20
10801902209372ARROWTELEFLEX INCORPORATEDDYG2022-05-20
20801902209379ARROWTELEFLEX INCORPORATEDDYG2022-05-20
10801902208979ARROWTELEFLEX INCORPORATEDDYG2022-03-18