FDA.reportPublic FDA data

ARROW

Primary DI
20801902180920
Brand
ARROW
Company
TELEFLEX INCORPORATED
Model
IPN917246
Catalog number
AH-05050
Device description
THERMODILUTION CATH KIT: 7.5 FR 5-L
Published
2021-08-17
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
DYGCATHETER, FLOW DIRECTED

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DYGCatheter, Flow DirectedCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K895268000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K895268000ARROW HANDS-OFF THERMO-PACEArrow Intl., Inc.1989-11-06DQO

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20801902180920PackageGS15In Commercial Distribution
10801902180923PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2080190218092020801902180920
1080190218092310801902180923

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Catheter Gauge7.5French
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

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
false
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
true
No natural rubber latex
false
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
10801902193114ARROWIPN920089CDC-29803-XCN1A2026-07-30
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

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